Actively Recruiting
Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer: a Prospective Single-center Multi-arm Open-label Randomized Phase II Study
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2023-08-08
100
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying locally advanced microsatellite stable (MSS) colon cancer to understand how combining neoadjuvant chemotherapy with immunotherapy and additional treatments affects tumor regression. This trial aims to improve long-term outcomes since current standard treatments often lead to recurrence or metastasis within several years. The study addresses the challenge that some patients resist oxaliplatin chemotherapy and that immunotherapy alone has limited effect in MSS colon cancer. Participants first receive two cycles of Capecitabine and Oxaliplatin (Capox) chemotherapy to identify those sensitive to treatment. Those who respond with significant tumor shrinkage are randomly assigned to one of three groups: continuing Capox chemotherapy alone, Capox plus an anti-PD-L1 monoclonal antibody, or Capox combined with both anti-PD-L1 antibody and Clostridium butyricum probiotic. After these treatments, patients undergo curative surgery with complete mesocolic excision. During the study, participants will have imaging evaluations, blood tests to measure immune markers and cytokines, and tumor tissue analyses before and after treatment. Researchers will monitor adverse events, surgical complications, disease-free survival, and overall survival over time. The main outcome is the proportion of patients showing significant tumor regression at surgery. The study follows patients for up to five years to assess long-term effects and monitor minimal residual disease through plasma testing.
CONDITIONS
Brief Title
Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older up to 75 years old
- Pathologically diagnosed microsatellite stable (MSS) or pMMR-type colon adenocarcinoma
- Tumor located more than 12 cm from the anus and not directly palpable during rectal exam
- Enhanced CT showing stage T3/T4 or T1-4N+ without multiple primary tumors or distant metastasis
- Life expectancy of more than 1 year
- First diagnosis with no prior anti-tumor treatment and no contraindications to chemotherapy
- Able to understand the study and provide written informed consent
You will not qualify if you...
- Refusal to participate in the study
- Multifocal colorectal cancer
- History of malignant tumors except basal cell carcinoma, papillary thyroid carcinoma, or in situ cancers
- Unable to tolerate chemotherapy (e.g., bone marrow suppression)
- Acute worsening of serious organ diseases or severe infections
- Mental disorders, illiteracy, or communication barriers preventing understanding of the study
- Tumor obstruction or high risk of obstruction, bleeding, or perforation
- Peripheral sensory neuropathy preventing oxaliplatin chemotherapy
- Pregnancy or lactation
- Unable to undergo enhanced CT or requiring glucocorticoid therapy
- Continuous glucocorticoid use for over 3 days within 1 month prior to consent
- Tumor lower border below specific anatomical landmarks on imaging
- Any condition the researcher deems unsuitable for the study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive 2 cycles of Capecitabine and Oxaliplatin (Capox) chemotherapy to evaluate tumor response.
Visits every 3 weeks for 2 cycles
Duration - Approximately 6 weeks
Participants who respond to induction chemotherapy are randomized to one of three groups: continue 2 more cycles of Capox chemotherapy alone, Capox chemotherapy combined with Anti-PD-L1 monoclonal antibody, or Capox chemotherapy combined with Anti-PD-L1 monoclonal antibody and Clostridium butyricum for 2 cycles.
Visits every 3 weeks for 2 cycles; weekly visits for Anti-PD-L1 administration during 6 weeks for applicable groups
Duration - 1 day
Participants undergo curative colectomy surgery to remove the tumor following neoadjuvant treatment.
1 visit (in-person surgery day)
Duration - Up to 6 months
Participants are monitored for adverse events, surgical complications, and tumor recurrence. Blood tests and molecular analyses are conducted at multiple timepoints up to 6 months after surgery.
Multiple visits for blood tests and assessments over 6 months
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
L
Li Jun, MD
J
Jiao Yurong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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