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

NCT ID: NCT05640726

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-05-01

Brief 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

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

(SCRT) followed by PD-1+ standard therapy

Group Type: EXPERIMENTAL

PD-1

Intervention Type: DRUG

Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks

SCRT

Intervention Type: RADIATION

Radiotherapy dose: 5×5 Gy

Bevacizumab

Intervention Type: DRUG

Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 of every 2 weeks

Oxaliplatin

Intervention Type: DRUG

Participants will receive Oxaliplatin，85mg/m2，day1

Calcium folinate

Intervention Type: DRUG

Participants will receive calcium folinate ，400mg/m2，day1

5-fluorouracil

Intervention Type: DRUG

Participants will receive 5-fluorouracil ，400mg/m2，day1

Interventions

PD-1

Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks

Intervention Type: DRUG

SCRT

Radiotherapy dose: 5×5 Gy

Intervention Type: RADIATION

Bevacizumab

Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 of every 2 weeks

Intervention Type: DRUG

Oxaliplatin

Participants will receive Oxaliplatin，85mg/m2，day1

Intervention Type: DRUG

Calcium folinate

Participants will receive calcium folinate ，400mg/m2，day1

Intervention Type: DRUG

5-fluorouracil

Participants will receive 5-fluorouracil ，400mg/m2，day1

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TCO002

Identifier Type: -

Identifier Source: org_study_id