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

NCT05640726 | Not Yet Recruiting Phase 2

• 1 other identifier: TCO002
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• progression free survival

  The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).

  up to 36 months

Secondary Outcomes (1)

• objective response rate

  every 3 months (up to 36 months）

Study Arms (1)

(SCRT) followed by PD-1+ standard therapy

EXPERIMENTAL

Drug: PD-1; Radiation: SCRT; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Calcium folinate; Drug: 5-fluorouracil

Interventions

PD-1 DRUG

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

(SCRT) followed by PD-1+ standard therapy

SCRT RADIATION

Radiotherapy dose: 5×5 Gy

(SCRT) followed by PD-1+ standard therapy

Bevacizumab DRUG

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

(SCRT) followed by PD-1+ standard therapy

Oxaliplatin DRUG

Participants will receive Oxaliplatin，85mg/m2，day1

(SCRT) followed by PD-1+ standard therapy

Calcium folinate DRUG

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

(SCRT) followed by PD-1+ standard therapy

5-fluorouracil DRUG

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

(SCRT) followed by PD-1+ standard therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Bevacizumab; Oxaliplatin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 7, 2022
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2026
• Last Updated: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share