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

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

NCT05640726•Fujian Cancer Hospital

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 75 years

Sex

ALL

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.

Key Dates

Start Date

May 1, 2023

Primary Completion Date

May 1, 2024

Completion Date

May 1, 2026

Last Updated

December 7, 2022

Enrollment

ESTIMATED participants

Conditions

Rectal Cancer

Interventions

PD-1

DRUG

SCRT

RADIATION

Bevacizumab

DRUG

Oxaliplatin

DRUG

Calcium folinate

DRUG

5-fluorouracil

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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