The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy

• Status: Not yet recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To explore the efficacy and safety of radiotherapy followed by PD-1+ standard chemotherapy in the first-line treatment of initial unresectable rectal cancer liver metastases

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

Details

• Lead Sponsor: Fujian Cancer Hospital
• Treatments: Bevacizumab; Calcium; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the rectum；

• The clinical stage evaluated by MRI was T3-4 and/or N+ and M1a(only liver metastasis)；

• ECOG PS 0-2；

• CHild Pugh A；

• Estimated survival ≥3 months;

• Women of childbearing age should comply with contraceptive measures if pregnancy test is negative;

• Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy;

• Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability.

Exclusion Criteria:

• Pregnant or lactating women;

• No previous antitumor therapy；

• No previous liver local therapy；

• No contraception during the reproductive period;

• patients known to have a history of allergy to any study drug, similar drug or excipient;

• Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;

• Patients with a history of thromboembolism, except those caused by PICC;

• Patients with active infection;

• Other conditions that the investigator determines are not suitable for inclusion in the study.