Changxing County People's Hospital
Huzhou, Zhejiang, 330522, China
Location status: Recruiting
Recruiting
NCT Number: NCT05742425
Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
- Age between 18 and 75 years
- Performance Status (ECOG) 0, 1 or 2, life expectancy > 12 weeks
- 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 </= 1.5 mg/dL
- 4. Hepatic function: AST (SGOT)/ALT (SGPT) </= 5 X institutional (Upper Limit of Normal) ULN.
- 5. Able to tolerate immunotherapy, chemotherapy and surgery.
- 6. Patients will be informed and a signed consent before initiating any procedure specific to the trial.
Exclusion criteria
- 1. Age >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
Treatment and study plan
Serplulimab Combined With FOLFIRI and Bevacizumab
DrugFor 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.
Primary outcomes
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Disease-free survival (DFS)
Time frame: 3 years
The period from the beginning of treatment to the first occurrence of disease progression or death from any cause. If such situation is not met, the last evaluation date shall be used for analysis. In addition, if the treatment is terminated without confirming the progress of the disease, the imaging examination and follow-up should also be carried out after the treatment is terminated.
Secondary outcomes
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Objective Remission Rate (ORR)
Time frame: 3 months after preoperative chemotherapy
The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit. The remission period usually refers to the period from the beginning of curative effect to the confirmation of tumor progression. The objective response rate is generally defined as the sum of complete response plus partial response (CR+PR).
-
3-year overall survival (OS)
Time frame: 3 years
The time from the date of treatment to the date of death due to any reason. For patients who survived in the final analysis, the date of the last contact will be recorded.
-
CC0/1 resection rate
Time frame: during operation
Complete tumor reduction surgery: CC-0: no peritoneal residual tumor; CC-1: residual tumor diameter<2.5mm.
-
Incidence rate of adverse events
Time frame: Baseline before any treatment,3 months after any treatment
According to NCI CTCAE v5.0
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Collaborators
- Changxing People's Hospital
Registry information
Official study title
The Efficacy and Safety of Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of pMMR/Ras/BRAF Wild-type Unresectable Colon Cancer Peritoneal Metastases: a Multicenter Single-arm Phase II Trial
Important dates
- Study start
- 2023
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Feb 24, 2023
- Registry last updated
- Feb 24, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.