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

NCT ID: NCT05640726

Condition: Rectal Cancer

Conditions: Official terms:
Rectal Neoplasms
Leucovorin
Bevacizumab
Oxaliplatin
Fluorouracil
Calcium
Levoleucovorin

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: PD-1
Description: Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
Arm group label: (SCRT) followed by PD-1+ standard therapy

Intervention type: Radiation
Intervention name: SCRT
Description: Radiotherapy dose: 5×5 Gy
Arm group label: (SCRT) followed by PD-1+ standard therapy

Intervention type: Drug
Intervention name: Bevacizumab
Description: Participants will receive bevacizumab,5mg/kg,intravenously over 60 - 90 minutes, day 1 of every 2 weeks
Arm group label: (SCRT) followed by PD-1+ standard therapy

Intervention type: Drug
Intervention name: Oxaliplatin
Description: Participants will receive Oxaliplatin,85mg/m2,day1
Arm group label: (SCRT) followed by PD-1+ standard therapy

Intervention type: Drug
Intervention name: Calcium folinate
Description: Participants will receive calcium folinate ,400mg/m2,day1
Arm group label: (SCRT) followed by PD-1+ standard therapy

Intervention type: Drug
Intervention name: 5-fluorouracil
Description: Participants will receive 5-fluorouracil ,400mg/m2,day1
Arm group label: (SCRT) followed by PD-1+ standard therapy

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

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Start date: May 1, 2023

Completion date: May 1, 2026

Lead sponsor:
Agency: Fujian Cancer Hospital
Agency class: Other

Source: Fujian Cancer Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05640726

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