Combining radiotherapy with PD-1 inhibitors for colorectal liver metastases

High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for Microsatellite Stable (MSS) Colorectal Liver Metastases (CRLM)

This study is testing if combining different doses of radiation therapy with a new type of cancer drug can help people with advanced colorectal cancer who haven't responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu Cancer Institute & Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06045286 on ClinicalTrials.gov

What this trial studies

This pilot phase I trial investigates the safety and efficacy of high- and low-dose radiotherapy combined with PD-1 inhibitors in patients with microsatellite stable metastatic colorectal cancer who have failed second-line immunotherapy or higher. The study will enroll 30 participants at Jiangsu Cancer Hospital. The goal is to assess whether this combination can improve treatment outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with microsatellite stable colorectal liver metastases who have failed second-line therapy and have an ECOG score of 0 or 1.

Not a fit: Patients requiring urgent surgical intervention or with severe allergies to the study drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with difficult-to-treat colorectal liver metastases.

How similar studies have performed: While this approach is novel, similar studies combining radiotherapy with immunotherapy have shown promising results in other cancer types.

Eligibility criteria

Inclusion Criteria:

1. Patients with microsatellite stable colorectal liver metastases and failure with second-line or above therapy, and no subsequent standard treatment regimen.
2. Patients with an ECOG score of 0 or 1, and an expected survival period of ≥6 months.
3. During the study, they are willing to follow the arrangement and not use other systemic anti-tumor drugs such as chemotherapy, targeted, Chinese herbal medicine, and proprietary Chinese medicine.
4. 18-70 years old, no gender limit.

Exclusion Criteria:

1. Those with a history of severe immediate allergy to the drugs used in this study.
2. Cancer patients who require urgent surgical intervention, such as high-risk pathological fractures, life-threatening bleeding symptoms, etc.
3. Any of the following conditions in the 6 months before screening: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient cerebral ischemia Onset or symptomatic pulmonary embolism. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria or left ventricular ejection fraction \<50% must adopt an optimized and stable medical plan determined by the treating doctor. If appropriate, you can consult a cardiologist.
4. Patients with active infection requiring systemic treatment.

Where this trial is running

Nanjing, Jiangsu

• Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Yuxuan Ding

Conditions Colorectal Liver Metastases; microsatellite stable; PD-1 Inhibitors; abscopal effects