New hope for advanced colon cancer: drug cocktail trial launches
NCT ID NCT07446387
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new combination of drugs for people with advanced colorectal cancer that cannot be removed by surgery. About 70 participants will receive two immunotherapy drugs plus a targeted therapy and chemotherapy. The goal is to see if this combination can shrink tumors and control the disease for as long as possible.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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\. Age 18-75 years; * 2\. Patients with histologically or cytologically confirmed unresectable, advanced colorectal cancer; * 3\. No prior systemic treatment; * 4\. ECOG PS score ≤2; * 5\. Expected survival ≥3 months; * 6\. MSS/MSI-L status; * 7\. At least one evaluable lesion based on RECIST 1.1 criteria; * 8\. No prior systemic chemotherapy or other systemic therapy, or only received adjuvant chemotherapy with disease progression or recurrence within 6 months after completion of treatment; * 9\. Adequate organ function reserve, with specific hepatic, renal, and hematologic parameters as follows: 1. White blood cell count ≥3.5×10⁹/L 2. Absolute neutrophil count ≥1.5×10⁹/L 3. Hemoglobin ≥100 g/L 4. Platelets ≥80×10⁹/L 5. Serum liver enzymes ≤2.5× upper limit of normal (ULN) in patients without liver metastases 6. Serum liver enzymes ≤5× ULN in patients with liver metastases 7. Serum bilirubin ≤1.5× ULN 8. Serum creatinine ≤1.5× ULN * 10\. No history of other malignancies; * 11\. Voluntary participation in this study with signed informed consent. Exclusion Criteria: * 1\. Prior hypersensitivity to any of the study drugs; * 2\. Active or known or suspected autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention; * 3\. Presence of non-measurable lesions (e.g., pleural effusion/ascites, carcinomatous lymphangitis, diffuse liver involvement, bone metastases); * 4\. Pregnant or lactating women; * 5\. Uncontrolled symptomatic brain metastases or psychiatric disorders preventing accurate expression of subjective symptoms; * 6\. Vital organ function failure; * 7\. Conditions affecting drug absorption/distribution/metabolism/excretion (e.g., seizures, central nervous system diseases, cognitive impairment due to psychiatric disorders, chronic diarrhea, cachexia, etc.); * 8\. Patients with complete or incomplete intestinal obstruction; * 9\. History of severe cardiac disease (including congestive heart failure, uncontrolled high-risk arrhythmia, angina requiring medication, definite valvular heart disease history, severe myocardial infarction, refractory hypertension); * 10\. Active infection requiring systemic treatment; * 11\. Known history of HIV infection; * 12\. Known history of hepatitis B or active hepatitis C virus infection; * 13\. Other conditions deemed unsuitable for enrollment by the investigator.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new pill plus cetuximab outsmart Hard-to-Treat colorectal cancer?
- Can mindfulness together ease the burden of advanced cancer?
- Can a Two-Pronged attack shrink Hard-to-Treat colorectal tumors?
- Blood test may reveal hidden cancer spread without scans
- Mouth bacteria may predict colon cancer drug resistance