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Trial Title:
Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases
NCT ID:
NCT05742425
Condition:
Unresectable Colon Cancer Peritoneal Metastases
PMMR/Ras/BRAF Wild-type
Conditions: Official terms:
Neoplasm Metastasis
Colonic Neoplasms
Peritoneal Neoplasms
Bevacizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Serplulimab Combined With FOLFIRI and Bevacizumab
Description:
For patients with confirmed failure to reach CC0/1, they should be treated with
sullizumab combined with FOLFIRI+bevacizumab for 4-8 cycles within 3 weeks after the
exploration operation. After the end of the 4th and 8th cycles, they should be evaluated
with imaging and MDT. If the conversion is successful, they should be treated with a
second exploration operation within 3-4 weeks, The patients with CC0/1 can be evaluated
for tumor reduction surgery (CRS) combined with intraperitoneal hyperthermic perfusion
chemotherapy (HIPEC), and the follow-up treatment plan will be selected according to the
clinical situation of the patients after surgery; If CC0/1 cannot be evaluated after the
second exploration surgery and CC0/1 cannot be performed after the imaging evaluation,
other chemotherapy and optimal supportive treatment will be performed according to the
situation.
Arm group label:
One-arm research group
Summary:
Multicentric randomised trial. The goal of this clinical research study is to evaluate
the efficacy and safety of serplulimab combined with FOLFIRI+bevacizumab in the treatment
of pMMR/Ras/BRAF wild-type unresectable peritoneal metastasis of colon cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Colon cancer was confirmed by histology, and its gene detection was pMMR/MSS
and RAS/BRAF wild-type. Imaging showed peritoneal metastasis.
-
2. Peritoneal metastatic carcinoma that could not reach CC0/1 was detected
surgically.
-
3. Patients with the following general characteristics:
1. Age between 18 and 75 years
2. Performance Status (ECOG) 0, 1 or 2, life expectancy > 12 weeks
3. Adequate renal, and bone marrow function: a. Leukocytes >/= 3,000/microL; b.
Absolute neutrophil count >/= 1,500/microL; c. Platelets >/= 100,000/Ul; d.
Serum creatinine 75years or age<18years.
-
2. Cancers of non colonic origin.
-
3. History of cancer (excepted cutaneous basal cell carcinoma or in situ carcinoma
of the uterine cervix) with a recurrence during the 5 previous years.
-
4. Known HIV, Hepatitis B or Hepatitis C positive.
-
5. Pregnant women or likely to be pregnant.
-
6. Persons under guardianship.
-
7. Subjects deemed unable to comply with study and/or follow-up procedures.
-
8. Subjects with a known hypersensitivity to protocol systemic chemotherapy that
was life-threatening, required hospitalization or prolongation of existing
hospitalization, or resulted in persistent or significant disability or
incapacity
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Changxing County People's Hospital
Address:
City:
Huzhou
Zip:
330522
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongwei Wu
Phone:
+86-0572-6023641
Start date:
March 2023
Completion date:
March 2028
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Changxing People's Hospital
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05742425
