Maintenance Anti-PD-1 Monoclonal Antibody + Capecitabine to Treat Metastatic Colorectal Cancer

• Status: Not yet recruiting
• Trial end date: 2029-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Surgery with integrated treatment for metastatic colorectal cancer (mCRC) has created a new clinical setting known as mCRC with no evidence of disease (NED). However, these patients have a high risk of developing persistent cancer. This study aimed to investigate the efficacy and safety of anti-PD-1 monoclonal antibody combined with capecitabine as a maintenance treatment for patients with mCRC-NED.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yanhong Deng
• Treatments: Antibodies; Antibodies, Monoclonal; Capecitabine

Criteria

Inclusion Criteria:

1. Age ≥ 20 years, < 80 years

2. Written informed consent

3. Histologically or cytologically confirmed CRC

4. Surgery with integrated treatment for metastatic colorectal cancer (mCRC) and achieved a statute of no evidence of disease (NED), as determined by a multidisciplinary tumor board.

5. cytoreduction surgery achieves CC0 (no visible residual tumor) if there is peritoneal metastasis

6. No previous chemotherapy

7. Synchronous or metachronous metastatic disease: maximum of two distant organs or regions involved

8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

9. Adequate hematologic and organ function

Exclusion Criteria:

1. Presence of any other active cancer

2. Presence of active infections requiring antibiotics

3. History of active autoimmune disease requiring systemic treatment