Different Cycles of Preoperative Neoadjuvant Sintilimab in Mismatch-repair Deficient/Microsatellite Instability-high, Locally Advanced Colorectal Cancer
- Registration Number
- NCT06698757
- Lead Sponsor
- Yugui Lian
- Brief Summary
Colorectal cancer is one of the most common malignant tumors, accounting for approximately 10% of new cancer cases and cancer-related deaths worldwide each year. In recent years, with the development of industrialization and urbanization, the increase in the number of elderly patients, and changes in dietary structure and lifestyle habits, the incidence and ...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 96
- has pathologically confirmed colon cancer or upper rectal cancer (with the lower edge of the tumor more than 10 cm from the anal verge); clinical stage cT3/T4 or N+
- no urgent need for surgery due to bleeding, perforation, or obstruction
- immunohistochemistry of tumor biopsy indicating deficient mismatch repair (dMMR), defined by the loss of expression of one or more of the four proteins MSH1, MSH2, MSH6, and PMS2; or genetic testing indicating MSI-H
- Has distant metastatic disease.
- Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
- Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization
- Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention
- There is a history of illness or evidence of disease, treatment, or abnormal laboratory test values that could potentially interfere with the trial results or hinder the subject's full participation in the study, or any other conditions deemed unsuitable for inclusion by the investigator.
- The investigator believes there are other potential risks that make the subject unsuitable for participation in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 8 cycles of neoadjuvant treatment with Sintilimab Sintilimab A total of 48 subjects were enrolled and received Sintilimab at a dose of 200 mg, administered via intravenous infusion on the first day of each cycle, with each cycle lasting 3 weeks (Q3W), for a total of 8 treatment cycles. 4 cycles of neoadjuvant treatment with Sintilimab Sintilimab A total of 48 subjects were enrolled and received Sintilimab at a dose of 200 mg, administered via intravenous infusion on the first day of each cycle, with each cycle lasting 3 weeks (Q3W), for a total of 4 treatment cycles.
- Primary Outcome Measures
Name Time Method the pathological complete response rate (pCR) From randomization up to a median of 5 years after randomization. Evaluate the pathological complete response rate (pCR) after surgery in patients with locally advanced dMMR/MSI-H colorectal cancer who received 4 cycles versus 8 cycles of neoadjuvant treatment with sintilimab.
- Secondary Outcome Measures
Name Time Method Event-free Survival (EFS) From randomization up to a median of 5 years after randomization. EFS is defined as the time from randomization to either disease recurrence or death due to any cause or treatment related toxicity that results in the participant not being suitable for surgery
Overall Survival (OS) From randomization up to a median of 5 years after randomization. OS is defined as time from randomization to death from any cause
Number of Participants with treatment emergent adverse events (AEs), serious adverse events (SAEs), Immune-mediated Adverse Event (imAEs), AEs leading to death and AEs leading to discontinuation of study treatment Up to approximately 5 years