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
|
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
Radiotherapy dose: 5×5 Gy
Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 of every 2 weeks
Participants will receive Oxaliplatin，85mg/m2，day1
Participants will receive calcium folinate ，400mg/m2，day1
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
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
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Micronutrients
- Vitamins
- Calcium-Regulating Hormones and Agents
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Bevacizumab
- Leucovorin
- Calcium
- Levoleucovorin
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.