New hope for advanced colon cancer: drug cocktail trial launches

NCT ID NCT07446387

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 to 75 years

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009, China

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Other studies related to the condition(s) this trial covers.