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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
