Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing toripalimab, a PD-1 immune-checkpoint inhibitor, together with cetuximab, which blocks EGFR, and irinotecan chemotherapy. They expect that combining immune activation, EGFR blockade and chemotherapy may control right-sided, RAS/BRAF-wild-type colon cancer after first-line treatment.
The trial asks whether this combination can produce tumour shrinkage in people whose cancer has progressed after first-line therapy; the main measure is the objective response rate, with progression-free and overall survival also followed. There is no comparison group, so the study cannot directly show that the combination is better than another second-line treatment.
Worth knowing: This is a small, single-arm phase II study, and its main endpoint is tumour response rather than longer survival.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07896681 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 46 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Toripalimab
- Drug Cetuximab
- Drug Irinotecan
What it is measuring
Objective Response Rate (ORR)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This phase II, single-arm clinical study aims to evaluate the efficacy and safety of toripalimab combined with cetuximab and irinotecan as second-line treatment for patients with advanced right-sided colon cancer with wild-type RAS and BRAF genes.
The study will enroll up to 46 adult patients with recurrent or metastatic right-sided colon cancer whose disease has progressed after first-line systemic therapy. Eligible patients must have wild-type RAS and BRAF genes and must not have previously received anti-EGFR antibodies or irinotecan.
All participants will receive toripalimab, cetuximab, and irinotecan by intravenous infusion every two weeks. Treatment will continue until disease progression, unacceptable toxicity, or other protocol-defined reasons for discontinuation.
The primary outcome is the objective response rate (ORR), assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary outcomes include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and treatment safety.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- RAS wild-type
- Metastatic
- Not yet treated
- Already treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
Participants must meet all of the following criteria to be eligible for this study:
1. Aged 18 years or older, regardless of sex.
2. Patients with previously treated recurrent or metastatic right-sided colon cancer.
3. Confirmed RAS and BRAF wild-type status based on molecular testing.
4. Disease progression following first-line systemic anticancer therapy that did not include anti-EGFR monoclonal antibodies or irinotecan.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, a life expectancy of at least 3 months, and the ability to cooperate with efficacy and safety assessments.
6. At least one measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
7.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07896681, registered by Cancer Institute and Hospital, Chinese Academy of Medical Sciences on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.