UnknownPhase 2

Phase II Study of Regorafenib and Toripalimab Combined With RFA in Patients With CRCLM

China32 participantsStarted 2022-07-25

Plain-language summary

The incidence of colorectal cancer liver metastasis is high and the prognosis is poor. Improving the treatment effect of colorectal cancer liver metastasis is the key to improving the prognosis of colorectal cancer patients. Rigofenib is one of the standard third-line treatments for advanced colorectal cancer, but has limited efficacy. Immune checkpoint inhibitors (PD-L1 monoclonal antibody, PD-1 monoclonal antibody) have achieved good results in the treatment of various malignant tumors. In a mouse transplant tumor model of colorectal cancer, regorafenib combined with PD-1 monoclonal antibody treatment significantly improved the antitumor activity, but the efficacy rate in clinical studies was not very high, especially for liver metastases. Radiofrequency ablation (RFA) is one of the common methods for the treatment of liver metastases. RFA may improve the immune microenvironment and the efficacy of immunotherapy,and the purpose of this trial is to explore the efficacy and safety of rigofenib and terepliumab combined with RFA in patients with refractory colorectal cancer liver metastasis.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males and females aged ≥18 years;
✓. Histologically or cytologically confirmed colon or rectal adenocarcinoma, with unresectable relapsed or metastatic disease;
✓. Microsatellite stability (MSS) or microsatellite instability-low (MSI-L), or proficient expression of DNA mismatch repair gene (pMMR);
✓. Patients who have failed, or can not tolerate after previous systemic treatment for relapsed or metastatic colorectal cancer, with no more than 3 months for disease progression after the last systemic treatment. The systemic treatment must contain fluorouracil, oxaliplatin and irinotecan, with or without targeted therapy (bevacizumab, cetuximab, and so on);
✓. According to the RECIST 1.1 standard, in addition to the lesion to be ablated and the measurable lesion outside the liver, there is at least one measurable lesion in the liver. Measurable lesions were defined as non-lymph node lesions with the longest single diameter ≥ 10 mm, or lymph node lesions with a short diameter ≥ 15 mm;
✓. ECOG score 0-1;
✓. Expected survival ≥3 months;
✓. Good organ function (without blood transfusion, use of hematopoietic stimulating factors, or transfusion of albumin or blood products within 14 days prior to examination):

What they're measuring

Objective response rate (ORR)

Timeframe: 2 years

Trial details

NCT IDNCT05485909

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-30

Contact for this trial

Zhiqiang Wang

+8613825122020 wangzhq@sysucc.org.cn

View on ClinicalTrials.gov More Colorectal Cancer Liver Metastases trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males and females aged ≥18 years;
✓. Histologically or cytologically confirmed colon or rectal adenocarcinoma, with unresectable relapsed or metastatic disease;
✓. Microsatellite stability (MSS) or microsatellite instability-low (MSI-L), or proficient expression of DNA mismatch repair gene (pMMR);
✓. Patients who have failed, or can not tolerate after previous systemic treatment for relapsed or metastatic colorectal cancer, with no more than 3 months for disease progression after the last systemic treatment. The systemic treatment must contain fluorouracil, oxaliplatin and irinotecan, with or without targeted therapy (bevacizumab, cetuximab, and so on);
✓. According to the RECIST 1.1 standard, in addition to the lesion to be ablated and the measurable lesion outside the liver, there is at least one measurable lesion in the liver. Measurable lesions were defined as non-lymph node lesions with the longest single diameter ≥ 10 mm, or lymph node lesions with a short diameter ≥ 15 mm;
✓. ECOG score 0-1;
✓. Expected survival ≥3 months;
✓. Good organ function (without blood transfusion, use of hematopoietic stimulating factors, or transfusion of albumin or blood products within 14 days prior to examination):

Phase II Study of Regorafenib and Toripalimab Combined With RFA in Patients With CRCLM

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Phase II Study of Regorafenib and Toripalimab Combined With RFA in Patients With CRCLM

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria