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Can radiation plus immunotherapy make colon tumors disappear before surgery?

NCT ID NCT06949111

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial is testing whether adding radiotherapy and immunotherapy to standard chemotherapy can shrink advanced colon tumors more effectively than chemotherapy alone. Adults with a specific type of stage T4M0 colon cancer will receive either the combination or chemotherapy only, followed by surgery if possible. The goal is to see if the combination improves complete tumor disappearance and increases the chance of successful surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radiotherapy combined with chemotherapy (CAPOX) and immunotherapy (iparomlimab and tuvonralimab)
What this could lead to
If successful, this combination could shrink advanced colon tumors enough to allow complete surgical removal, potentially improving long-term outcomes and preserving nearby organs.
What could go wrong
This is an early-phase trial with a modest number of participants, so results may not hold in larger groups. Combining radiation, chemotherapy, and immunotherapy can also increase the risk of side effects.

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 128 people

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

Started

May 2025

Expected to finish

Mar 2030

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

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 years, no restriction on gender. 2. ECOG performance status of 0-1. 3. Histopathologically confirmed diagnosis of colon adenocarcinoma (including mucinous adenocarcinoma), identified as pMMR/MSS type; the primary tumor site must be specified (left colon defined as from the splenic flexure to the rectosigmoid junction, right colon defined as from the cecum to the proximal splenic flexure). 4. Baseline imaging (enhanced CT/MRI) confirms clinical staging as cT4NanyM0 according to the AJCC 8th edition staging criteria. 5. Laboratory criteria prior to enrollment must meet the following ranges: (1) Hematology: Absolute neutrophil count ≥ 1.5 × 10\^9/L, platelets ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L. (2) Liver and renal function: ALT/AST ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN, creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (Cockcroft-Gault formula). (3) Coagulation function: INR ≤ 1.5, APTT ≤ 1.5 × ULN (for those not on anticoagulation therapy). 6.Women of childbearing potential and men must agree to use effective contraception during the study and for 6 months after the last treatment. 7.Willingness to sign a written informed consent form and commit to completing the entire treatment and follow-up plan. Exclusion Criteria: 1. Histological type of neuroendocrine carcinoma, squamous cell carcinoma, or other non-adenocarcinoma components comprising more than 50%. 2. Presence of distant metastasis (including peritoneal metastasis, non-regional lymph node metastasis, or organ metastasis). 3. Previous radiotherapy, chemotherapy, targeted therapy, or immunotherapy for colon cancer. 4. Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis requiring long-term immunosuppressive therapy). 5. Active infections (e.g., HIV, positive HBV/HCV viral load requiring antiviral treatment for stabilization). 6. Severe cardiovascular diseases (e.g., myocardial infarction within 6 months, unstable angina, uncontrolled hypertension \>160/100 mmHg). 7. History of other malignancies (except for cured non-melanoma skin cancer, cervical carcinoma in situ, etc., with a disease-free period of ≥5 years). 8. Uncontrolled diabetes (HbA1c \> 8%) or thyroid dysfunction (TSH outside the normal range requiring medication). 9. Severe chronic bowel diseases (e.g., active Crohn's disease, ulcerative colitis). 10. History of radiation enteritis or extensive abdominal adhesions affecting radiotherapy target delineation. 11. Unrecovered bone marrow suppression (ANC \< 1.5 × 10\^9/L, PLT \< 100 × 10\^9/L, Hb \< 90 g/L). 12. Liver function with Child-Pugh score ≥ B or renal function with eGFR \< 60 mL/min/1.73 m². 13. Pregnant or breastfeeding women (blood/urine HCG test required during screening). 14. Cognitive impairment or history of psychiatric disorders affecting treatment compliance. 15. Concurrent participation in other interventional clinical trials. 16. Patients deemed unsuitable for participation 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

  • the Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050000, China

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