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Clinical Trials mCRC

USA

Category
Trial acronym
Title
Link
Interventional Oncology
TACE-Ax-HCQ
TACE Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Colorectal Cancer (CRC) (TACE-Ax-HCQ)- Patients with liver dominant mCRC who have failed at least one line of systemic therapy receive 2 weeks of axitinib 5mg 2x day (BID) and HCQ 600 mg (BID) followed by lobar or segmental TACE monthly until entire tumor burden is treated, then continue axitinib/HCQ until progression or intolerable toxicity. Response and hepatic progression-free survival (HPFS) will be assessed one-month post-TACE, then every 3 months
Medical Oncology
SCOTI
Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late Line Metastatic Colorectal Cancer- Evaluate efficacy of TAS-OX alternating with TAS-IRI (sequential TASOXIRI) with Bevacizumab, in the treatment of mCRC. Phase II
Medical Oncology
Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer- An open-label, single-arm, 2-stage, phase II study of cabozantinib in combination with nivolumab in patients with refractory metastatic CRC. Up to 46 evaluable patients will be treated with cabozantinib 40 mg orally daily in combination with nivolumab 480 mg IV every 28 days. One cycle is defined as 28 days.
Medical Oncology
SEAMARK
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer- A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI H/DMMR METASTATIC COLORECTAL CANCER
Interventional oncology
ACCLAIM
Ablation With Confirmation of Colorectal Liver Metastases
Medical Oncology
ZN-c3 in Adult Participants With Metastatic Colorectal Cancer- A Phase 1/2, Open-Label, Multi-Center Study of ZN-c3 Administered in Combination With Encorafenib and Cetuximab in Adults With Metastatic Colorectal Cancer
Medical Oncology Surgical Oncology
DNX-2440 for Resectable Colorectal Liver Metastasis- A Phase I Safety and Window-of-opportunity Study of Preoperative Intratumoral Injection of OX40-ligand Expressing Oncolytic Adenovirus (DNX-2440) in Patients With Resectable Liver Metastasis
Medical Oncology Surgical Oncology
ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
Radiation oncology
A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic
Resonance Imaging (MRI) in People With Liver Metastasis From Colorectal Cancer
Medical Oncology
Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer- prospective phase II, single arm, single site trial will evaluate the efficacy of the combination of liposomal irinotecan (nal-IRI), TAS102, and bevacizumab for the treatment of patients with mismatch repair proficient, metastatic or unresectable colorectal cancer that has previously been treated with 5-fluorouracil, oxaliplatin, irinotecan and if RAS wild-type an anti-EGFR agent.
Medical Oncology
STIMVAX
Immunotherapy for Third Line Metastatic Colorectal Cancer- Phase IIB multi-site, open label study of a next generation immunotherapy for third-line MSI-S metastatic colorectal cancer using an "off-the-shelf", non-genetically manipulated living immune cell product (AlloStim) derived from the blood of healthy donors
Medical Oncology
Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver
Interventional oncology
Tissue Analysis After Thermal Ablation for Colon Cancer Liver Metastases Leading to Immediate Retreatment
Medical Oncology Surgical Oncology
Patient Outcomes After Hepatic Artery Infusion Pump Placement
Radiation Oncology Surgical Oncology
Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases
Surgical Oncology
Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
Medical oncology
DNX-2440 for Resectable Colorectal Liver Metastasis
Radiation oncology
Study of TAS-102 Plus Radiation Therapy for the Treatment of the Liver in Patients With Hepatic Metastases From Colorectal Cancer
Medical oncology Surgical oncology
Preoperative Immunotherapy (Pembrolizumab) for Patients With Colorectal Cancer and Resectable Hepatic Metastases
Radiation oncology
MOMENTUM
The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

Canada

Category
Trial acronym
Title
Link
Surgical oncology
Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases
Medical oncology Surgical oncology
PERIOP-06
A Study of QBECO Versus Placebo in the Treatment of Colorectal Cancer That Has Spread to the Liver

Brasil

Category
Trial acronym
Title
Link
Radiation oncology
Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

United Kingdom

Category
Trial acronym
Title
Link
Medical oncology
Prebiotic Effect of Eicosapentaenoic Acid Treatment for Colorectal Cancer Liver Metastases
Medical oncology
ACT
PS101-mediated ACT With Chemotherapy in Liver Metastases From Cancer of Gastrointestinal Origin

The Netherlands

Category
Trial acronym
Title
Link
Medical oncology
CAIRO5
Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases
Medical oncology Surgical oncology
CAIRO 6
Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for resectable colorectal peritoneal metastases: a multicentre, open-label, parallel-group, phase II-III, randomised superiority study
Interventional oncology
CAIRO 7
Radioembolization with 166Ho-microspheres in elderly and/or fragile patients with previously untreated unresectable liver-only metastases of colorectal cancer
Interventional oncology Surgical oncology
COLLISION
Colorectal liver metastases: surgery versus thermal ablation – a phase III single-blind prospective randomized controlled trial
Interventional oncology Radiation oncology
COLLISION-XL
Unresectable colorectal liver metastases: stereotactic body radiotherapy versus microwave ablation – a phase II prospective randomized controlled trial for CRLM 3-5 cm
Medical oncology Interventional oncology Surgical oncology
COLLISION RELAPSE
Recurrent Colorectal Liver Metastases: Repeat Local Treatment +/- Neoadjuvant Systemic Therapy - a Phase III Prospective Randomized Controlled Trial
Medical oncology
INTERACT-II
Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases – a phase II study
Medical oncology Interventional oncology Surgical oncology Radiation oncology
ORCHESTRA
A randomized multicenter clinical trial for patients with multi-ORgan, Colorectal cancer metastases comparing the combination of cHEmotherapy and maximal tumor debulking versuS chemoTheRapy Alone
Medical oncology
INTERACT-II
Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with
unresectable colorectal peritoneal metastases – a phase II study
Medical oncology Surgical oncology
PIPAC-II
Bidirectional treatment consisting of repetitive laparoscopic electrostatic pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) and systemic intravenous chemotherapy for isolated unresectable colorectal peritoneal metastases: feasibility, safety, tolerability, and preliminary efficacy
Medical oncology Surgical oncology
PUMP-III
Adjuvant hepatic arterial infusion pump chemotherapy after repeat hepatectomy for patients with liver confined recurrence of colorectal cancer – a phase II study
Medical oncology Surgical oncology
PUMP-IT pilot
Hepatic arterial infusion PUMP chemotherapy combined with systemic chemoTherapy for potentially resectable colorectal liver metastases.
Medical oncology Surgical oncology
PUMP
Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases in patients with a low clinical risk score – a randomized controlled trial
Interventional oncology Surgical oncology
DRAGON 2
An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE/HVE) With PVE Alone in Patients With Colorectal Liver Cancer Metastases (CRLM) and a Small Future Liver Remnant (FLR)

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Germany

Category
Trial acronym
Title
Link
Surgical oncology
ARMANI
Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer
Surgical oncology
LIVERT(W)OHEAL
Living Donor Liver Transplantation With Two Stage Hepatectomy for Patients With Isolated, Irresectable Colorectal Liver Metastases

Denmark

Category
Trial acronym
Title
Link
Radiation oncology Interventional oncology
Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver
Interventional oncology
ISCOLIM
Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation
Radiation oncology
SIRT
Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases

Norway

Category
Trial acronym
Title
Link
Interventional oncology Surgical oncology
NEW-COMET
Ablation vs Resection of Colorectal Cancer Liver Metastases
Surgical oncology Medical oncology
SECAIII
Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer
Medical oncology Interventional oncology Surgical oncology
EXCALIBUR3
EXtended CriteriA Treatment for LIver Metastases and Heavy Tumour BURden
Surgical oncology
Liver Transplantation and Colorectal Cancer
Medical oncology
EXCALIBUR1+2
HAI-Floxuridine, or Liver-Tx, Combined With 2nd Line Chemotherapy Versus 2nd Line Chemotherapy Alone for Patients With Colorectal Liver Metastases and Heavy Tumour Burden
Surgical oncology
Partial Liver Segment 2/ 3 Transplantation Study

Sweden

Category
Trial acronym
Title
Link
Surgical oncology
SOULMATE
The Swedish Study of Liver Transplantation for Non-resectable Colorectal Cancer Metastases

France

Category
Trial acronym
Title
Link
Surgical oncology
METALAP
Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases
Surgical oncology Interventional oncology
HYPER-LIV01
Simultaneous Portal and Hepatic Vein Versus Portal Vein Embolizations for Hypertrophy of the Future Liver Remnant
Medical oncology
CETIDYL
Cetuximab as Salvage Therapy in Patients With Neo Wild-type RAS/ RAF Metastatic Colorectal Cancer With Liver Metastases
Medical oncology
OSCAR
Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/ - Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver

Italy

Category
Trial acronym
Title
Link
Surgical oncology
RAPID-Padova
The Swedish Study of Liver Transplantation for Non-resectable Colorectal Cancer Metastases Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy
Surgical oncology
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
Surgical oncology
COLT
Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation
Surgical oncology
LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis (LIVERMORE)

Spain

Category
Trial acronym
Title
Link
Surgical oncology
TRASMETIR
Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
Surgical oncology
Liver Transplantation for Non-resectable Colorectal Liver Metastases: Translational Research
Interventional oncology Medical oncology
LIVERPEARL
Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease

Australia

Category
Trial acronym
Title
Link
Medical oncology
SYS-CAPLIOX
The Swedish Study of Liver Transplantation for Non-resectable Colorectal Cancer Metastases

China

Category
Trial acronym
Title
Link
Interventional oncology Surgical oncology
HELARC
Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis
Surgical oncology
Minimally Invasive Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases
Interventional oncology Medical oncology
The Safety and Efficacy of HAIC+Tislelizumab+Regorafenib in Patients With Colorectal Liver Metastases
Interventional oncology Medical oncology
Hepatic Arterial Infusion Chemotherapy Combined With Sintilimab and Regorafenib as Adjuvant Therapy for Colorectal Liver Metastasis Patients With a High Risk of Recurrent: a Single-arm, Phase II Study
Radiation oncology
HaRyPOT
High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for MSS CRLM
Medical Oncology
Exploratory Study on Combined Conversion Immunotherapy for Liver Metastasis of MSS Type Initial Unresectable Colorectal Cancer Based on Gene Status
Medical oncology
Conversion Therapy of RAS/ BRAF Wild-Type Colorectal Cancer Patients With Initially Unresectable Liver Metastases
Radiation oncology
NRT-uCRLM
Yttrium-90 Carbon Microspheres in Patients With Unresectable Colorectal Liver Metastases
Medical oncology
Anti-CEA CAR-T Cells to Treat Colorectal Liver Metastases
Medical oncology
mFOLFOXIRI+Bev vs. mFOLFOX6+Bev for RAS Mutant Unresectable Colorectal Liver-limited Metastases
Medical Oncology
3D Bioprinted Models for Predicting Chemotherapy Response in Colorectal Cancer With/ Without Liver Metastases
Medical oncology Interventional oncology
Phase II Study of Regorafenib and Toripalimab Combined With RFA in Patients With CRCLM
Medical oncology Interventional oncology
Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis
Medical oncology Interventional oncology
RIDER
Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases
Medical oncology Interventional oncology
Systemic Chemotherapy Plus HAI(FUDR) vs Systemic Chemotherapy Alone For CRCLM
Medical oncology Radiation oncology
IMPROVE
Postoperative Chemotherapy With/ Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence
Medical oncology Interventional oncology
Hepatic Arterial Infusion Chemotherapy With Fruquintinib for Colorectal Cancer Liver Metastases As Third-line Therapy
Medical oncology
FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases
Radiation oncology
Curative Proton Beam Therapy for Patients With Liver Metastasis of Colorectal Cancer
Medical oncology
ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer
Medical oncology
Efficacy of Modified Fruquintinib in Colorectal Cancer Liver Metastases: A Phase II Study
Medical oncology Interventional oncology
Fruquintinib Combined With Tislelizumab and HAIC in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard Therapy
Medical oncology
TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer
Medical oncology Interventional oncology
A Study of Systemic Chemotherapy With/ Without HAI in Patients With Initially Unresectable Colorectal Liver Metastasis
Medical oncology
Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA

Korea

Category
Trial acronym
Title
Link
Surgical oncology
LT for Unresectable Colorectal Liver Metastasis

Vietnam

Category
Trial acronym
Title
Link
Medical oncology
Surgery Outcome Treated by Neo-adjuvant Combination of Oxaliplatin, Irinotecan, Folinic Acid and Fluorouracil (FOLFOXIRI) Regimen in Synchronous Liver Limited Metastasis Colorectal Cancer

Singapore

Category
Trial acronym
Title
Link
Medical oncology
Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC

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Recent Literature

  1. Morris VK, Kennedy EB, Baxter NN, Benson AB 3rd, Cercek A, Cho M, Ciombor KK, Cremolini C, Davis A, Deming DA, Fakih MG, Gholami S, Hong TS, Jaiyesimi I, Klute K, Lieu C, Sanoff H, Strickler JH, White S, Willis JA, Eng C. Treatment of Metastatic Colorectal Cancer: ASCO Guideline. J Clin Oncol. 2023 Jan 20;41(3):678-700. doi: 10.1200/JCO.22.01690. Epub 2022 Oct 17. PMID: 36252154; PMCID: PMC10506310.
  2. Waddell, J.J., Townsend, P.H., Collins, Z.S. et al. Liver-Directed Therapy for Metastatic Colon Cancer: Update. Curr Colorectal Cancer Rep 18, 18–25 (2022). https://doi.org/10.1007/s11888-022-00474-1 
  3. Scarabel L, Bignucolo A, Toffoli G, Cecchin E, De Mattia E. Pharmacogenetics Role of Genetic Variants in Immune-Related Factors: A Systematic Review Focusing on mCRC. Pharmaceutics. 2022; 14(11):2468. https://doi.org/10.3390/pharmaceutics14112468
  4. Xiong F, Zhou YW, Hao YT, Wei GX, Chen XR, Qiu M. Combining Anti-epidermal Growth Factor Receptor (EGFR) Therapy with Immunotherapy in Metastatic Colorectal Cancer (mCRC). Expert Rev Gastroenterol Hepatol. 2023 Sep 13:1-8. doi: 10.1080/17474124.2023.2232718. Epub ahead of print. PMID: 37705376.
  5. Zhao J, Shi L, Ji M, Wu J, Wu C. The combination of systemic chemotherapy and local treatment may improve the survival of patients with unresectable metastatic colorectal cancer. Mol Clin Oncol. 2017 Jun;6(6):856-860. doi: 10.3892/mco.2017.1247. Epub 2017 May 8. PMID: 28588777; PMCID: PMC5451863.
  6. Arellano RS. What’s New in Percutaneous Ablative Strategies for Hepatocellular Carcinoma and Colorectal Hepatic Metastases? 2020 Update. Curr Oncol Rep. 2020 Jul 28;22(10):105. doi: 10.1007/s11912-020-00967-y. PMID: 32725433.
  7. Camacho JC, Petre EN, Sofocleous CT. Thermal Ablation of Metastatic Colon Cancer to the Liver. Semin Intervent Radiol. 2019 Oct;36(4):310-318. doi: 10.1055/s-0039-1698754. Epub 2019 Oct 31. PMID: 31680722; PMCID: PMC6823045.
  8. Alonso, J., Casans, I., González, F. et al. Economic evaluations of radioembolization with yttrium-90 microspheres in liver metastases of colorectal cancer: a systematic review. BMC Gastroenterol 23, 181 (2023). https://doi.org/10.1186/s12876-023-02793-5
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  10. González-Flores E, Zambudio N, Pardo-Moreno P, Gonzalez-Astorga B, de la Rúa JR, Triviño-Ibáñez EM, Navarro P, Espinoza-Cámac N, Casado MÁ, Rodríguez-Fernández A. Recommendations for the management of yttrium-90 radioembolization in the treatment of patients with colorectal cancer liver metastases: a multidisciplinary review. Clin Transl Oncol. 2023 Sep 25. doi: 10.1007/s12094-023-03299-y. Epub ahead of print. PMID: 37747636.