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

December 6, 2022 updated by: Fujian Cancer Hospital
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: up to 36 months
The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).
up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: every 3 months (up to 36 months）
Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).
every 3 months (up to 36 months）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2026

Study Registration Dates

First Submitted

November 25, 2022

First Submitted That Met QC Criteria

December 6, 2022

First Posted (Estimate)

December 7, 2022

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCO002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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