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New combo therapy shows promise for Hard-to-Treat colorectal cancer

NCT ID NCT07512674

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 treatment approach for people with advanced colorectal cancer that has spread to the liver, lungs, or abdomen and cannot be removed with surgery. The treatment combines a short course of radiation with immunotherapy (tislelizumab), chemotherapy (CAPOX), and a targeted drug (bevacizumab). The goal is to see if this combination can shrink tumors and control the disease. The study involves 33 participants and is currently active but no longer recruiting.

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 33 people

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

Started

Feb 2026

Expected to finish

Mar 2027

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\. Voluntarily participate in this study and provide written informed consent. Good compliance and ability to comply with follow-up procedures. 2\. Age ≥ 18 years. 3. Primary tumor located in the colon or rectum. 4. Histologically confirmed adenocarcinoma; pMMR by immunohistochemistry or MSS by genetic testing. 5\. Metastatic disease confirmed by contrast-enhanced or non-contrast CT or contrast-enhanced MRI within 3 weeks before enrollment; at least one measurable lesion in the liver and/or lung, or peritoneal cavity (RECIST 1.1); metastatic lesions assessed as initially unresectable by multidisciplinary discussion. 6\. ECOG performance status 0-1. 7. Life expectancy ≥ 3 months. 8. Adequate organ and bone marrow function: 1. Hemoglobin ≥ 6.0 mmol/L, 2. Absolute neutrophil count ≥ 1.5 ×10⁹/L, 3. Platelet count ≥ 100 ×10⁹/L; 4. Renal function: serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 30 mL/min; 5. Hepatic function: serum bilirubin ≤ 2 × ULN, serum transaminases ≤ 5 × ULN. 9. No contraindications to surgery. Exclusion Criteria: * 1\. Prior treatment with PD-1, PD-L1, or other immune checkpoint inhibitors. 2. Prior receipt of any anti-tumor therapy for colorectal cancer, including radiotherapy, chemotherapy, or tumor resection surgery. 3\. Microsatellite instability-high (MSI-H) or DNA mismatch repair deficiency (dMMR). 4\. Presence of brain metastases. 5. Participation in another clinical trial of anti-tumor agents within 4 weeks prior to enrollment. 6\. History of hypersensitivity to monoclonal antibodies, any component of tislelizumab, capecitabine, oxaliplatin, or bevacizumab. 7\. Receipt of local treatments including transarterial chemoembolization, microwave ablation, radiofrequency ablation, SBRT, or metastasectomy for liver or lung metastases within 4 weeks prior to enrollment. 8\. Confirmed immunodeficiency disease or active autoimmune disease, including but not limited to systemic lupus erythematosus, inflammatory bowel disease, myasthenia gravis, autoimmune hepatitis, rheumatoid arthritis, multiple sclerosis, glomerulonephritis, vasculitis; use of other immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 4 weeks prior to enrollment. 9\. Known human immunodeficiency virus (HIV) infection; clinically significant liver disease including viral hepatitis \[active HBV infection (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), hepatitis C (positive anti-HCV antibody with HCV RNA above the lower limit of detection)\]. 10\. Uncontrolled hypertension, or inadequate blood pressure control despite treatment with ≥ 3 antihypertensive agents. 11\. Disease with severe bleeding risk such as gastrointestinal bleeding, bleeding diathesis, or thrombotic disease requiring long-term oral anticoagulants or antiplatelet agents. 12\. Uncontrolled cardiac symptoms or diseases including but not limited to: 1. NYHA class ≥ II heart failure; 2. unstable angina; 3. myocardial infarction within 1 year; 4. clinically significant supraventricular or ventricular arrhythmias that are uncontrolled or poorly controlled despite intervention. 13\. Severe infection (CTCAE grade \> 2) within 4 weeks prior to the first study drug administration, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; active pulmonary inflammation on baseline chest imaging; signs or symptoms of infection or requirement for oral or intravenous antibiotics within 14 days before the first study drug administration (excluding prophylactic antibiotics); active tuberculosis confirmed by history or CT, history of active tuberculosis within 1 year prior to enrollment, or history of active tuberculosis more than 1 year prior without standard treatment. 14\. Diagnosis of another malignancy within 5 years prior to the first study drug administration, except malignancies with low risk of metastasis or death (5-year survival \> 90%), such as adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. 15\. Pregnant or lactating female. 16. Other vulnerable populations, including patients with psychiatric disorders, cognitive impairment, or critical illness. 17\. Any other condition judged by the investigator that may lead to premature study discontinuation, such as other serious diseases (including psychiatric disorders) requiring concurrent treatment, alcoholism, drug abuse, family or social factors that may affect subject safety or compliance.

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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.

Contacts and locations

Locations

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, China