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

Phase 2

Not yet recruiting

• Conditions: Rectal Cancer
• Interventions: Drug: PD-1; Radiation: SCRT; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Calcium folinate; Drug: 5-fluorouracil

• Registration Number: NCT05640726
• Lead Sponsor: Fujian Cancer Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-25
• Study First Submitted QC: 2022-12-06
• Last Update Submitted: 2022-12-06
• Study First Posted: 2022-12-07
• Last Update Posted: 2022-12-07
• Study Start: 2023-05-01
• Primary Completion: 2024-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
(SCRT) followed by PD-1+ standard therapy	PD-1	-
(SCRT) followed by PD-1+ standard therapy	SCRT	-
(SCRT) followed by PD-1+ standard therapy	Bevacizumab	-
(SCRT) followed by PD-1+ standard therapy	Calcium folinate	-
(SCRT) followed by PD-1+ standard therapy	Oxaliplatin	-
(SCRT) followed by PD-1+ standard therapy	5-fluorouracil	-

Primary Outcome Measures

Name	Time	Method
progression free survival	up to 36 months	The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).

Secondary Outcome Measures

Name	Time	Method
objective response rate	every 3 months (up to 36 months）	Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).