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New treatment option for Unresectable Colon Cancer Peritoneal Metastases
Official title Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases
ClinicalTrials.gov ID: NCT05742425
What this study is testing
What is Serplulimab Combined With FOLFIRI and Bevacizumab?
Serplulimab Combined With FOLFIRI and Bevacizumab is an investigational medicine, being studied as a potential treatment for unresectable colon cancer peritoneal metastases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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...
- 4\. Known HIV, Hepatitis B or Hepatitis C positive.
- 5\. Pregnant women or likely to be pregnant.
- 6\. Persons under guardianship.
See the full eligibility 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.
- 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\. people deemed unable to comply with study and/or follow-up procedures.
- 8\. people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Huzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.