Can two immune boosters outsmart Chemo-Resistant colon cancer?
NCT ID NCT07729605
First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time
Summary
This phase 3 trial is testing whether adding two immune-boosting drugs, iparomlimab and tuvonralimab, to standard chemotherapy can help people with a specific type of metastatic colorectal cancer that has stopped responding to first-line treatment. The study includes about 270 adults whose tumors are microsatellite stable (MSS), a form that typically does not respond well to immunotherapy alone. Researchers are measuring whether the combination extends the time before the cancer grows again, and also tracking overall survival, tumor shrinkage, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of chemotherapy (FOLFIRI), bevacizumab, and two immune checkpoint inhibitors (iparomlimab and tuvonralimab)
- What this could lead to
- If successful, this could offer a new second-line treatment option for people with a common type of metastatic colorectal cancer that has not responded to initial therapy.
- What could go wrong
- This is an early-phase trial, so the added benefit of the immune drugs is unproven. Immune checkpoint inhibitors can cause serious side effects, and the combination may not improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 270 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jul 2026
An estimate. Start dates often move.
- Expected to finish
-
Jul 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Willing and able to provide written informed consent. 2. Age ≥ 18 years old. 3.Histologically confirmed metastatic colorectal adenocarcinoma with pMMR/MSS status. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 5.Discontinued first-line oxaliplatin-based doublet chemotherapy for metastatic colorectal cancer due to intolerable toxicities or disease progression; OR developed recurrent metastatic disease within 6 months after the last dose of adjuvant chemotherapy. 6.Presence of evaluable lesions on imaging examinations. 7. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment. 8.Willing and able to comply with study procedures and scheduled visit schedules Exclusion Criteria: * 1.Patients complicated with digestive tract diseases including duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions judged by the investigator to potentially cause gastrointestinal hemorrhage or perforation; or massive pleural effusion or ascites requiring intervention. 2.Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization. 3. Radiological evidence of brain metastases. 4. Prior treatment with irinotecan hydrochloride, or prior receipt of PD-1 and/or CTLA-4 immunotherapy in the first-line setting. 5. Autoimmune diseases requiring continuous systemic steroid therapy. 6. History of laparotomy, thoracotomy or intestinal resection within 28 days prior to enrollment; or unhealed wounds (excluding suture wounds from central venous catheter implantation), gastrointestinal ulcers or traumatic fractures. 7. Any of the following events occurring within 12 months before study enrollment: myocardial infarction, severe/unstable angina pectoris, New York Heart Association (NYHA) class ≥ 2 cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure. 8.Confirmed human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases. 9. Active inflammatory bowel disease or other colorectal diseases causing chronic diarrhea; interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, acute pneumonia, etc.). 10. Breastfeeding or pregnant women; lack of effective contraceptive. 11. Other severe physical or psychiatric illnesses, or laboratory abnormalities that may increase the risks of study participation or interfere with study outcomes; or patients deemed unsuitable for this study by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Colorectal cancer metastatic are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
The sixth affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a daily pill replace chemotherapy for advanced colorectal cancer?
- Can a Three-Drug combo outsmart Hard-to-Treat colorectal cancer?
- Can a smart drug home in on Hard-to-Treat cancers?
- Can a vaccine boost immunotherapy against a stubborn cancer?
- What does recovery really look like after aggressive peritoneal cancer surgery?
- Chemo holidays put to the test: can scheduled breaks beat continuous treatment for advanced colorectal cancer?