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

Sponsor

Fujian Cancer Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05640726

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Drug: PD-1 Radiation: SCRT Drug: Bevacizumab Drug: Oxaliplatin Drug: Calcium folinate Drug: 5-fluorouracil	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: (SCRT) followed by PD-1+ standard therapy	Drug: PD-1 Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks Radiation: SCRT Radiotherapy dose: 5×5 Gy Drug: Bevacizumab Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 of every 2 weeks Drug: Oxaliplatin Participants will receive Oxaliplatin，85mg/m2，day1 Drug: Calcium folinate Participants will receive calcium folinate ，400mg/m2，day1 Drug: 5-fluorouracil Participants will receive 5-fluorouracil ，400mg/m2，day1

Arm

Intervention/Treatment

Experimental: (SCRT) followed by PD-1+ standard therapy

Drug: PD-1

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

Radiation: SCRT

Radiotherapy dose: 5×5 Gy

Drug: Bevacizumab

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

Drug: Oxaliplatin

Participants will receive Oxaliplatin，85mg/m2，day1

Drug: Calcium folinate

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

Drug: 5-fluorouracil

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.