Actively Recruiting
Neoadjuvant Treatment of Locally Advanced MSS Rectal Cancer With Tislelizumab Combined With CAPOX Regimen: a Prospective, Single-arm, Single-center, Exploratory Phase II Clinical Study
Led by First Affiliated Hospital of Guangxi Medical University ยท Updated on 2024-02-12
60
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the effects of using neoadjuvant Tislelizumab combined with chemotherapy in treating locally advanced microsatellite stable (MSS) rectal cancer. The standard care for this condition involves chemoradiotherapy followed by surgery, which reduces recurrence risk but can cause side effects affecting quality of life. This study explores a different approach by combining immunotherapy with chemotherapy to potentially improve treatment outcomes. Participants will receive two or four cycles of treatment combining Tislelizumab, Oxaliplatin, and Capecitabine before undergoing total mesorectal excision (TME) surgery. Oxaliplatin is given intravenously every three weeks, Capecitabine is taken orally twice daily for two weeks, and Tislelizumab is administered every three weeks. Following these treatments, patients will have surgery to remove the tumor. Throughout the study, participants will be monitored with enhanced CT scans, MRI, and ultrasound to evaluate their response before surgery. Researchers will assess the primary outcome by examining the rate of complete tumor response in surgical specimens within seven days after surgery. Secondary outcomes include clinical response rates, survival rates over three years, adverse event rates, surgical complications, and local recurrence. Participants will be followed for up to three years after treatment to track these outcomes and overall safety.
CONDITIONS
Brief Title
The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years old and 70 years old or younger.
- Pathologically diagnosed microsatellite stable (MSS) colon adenocarcinoma confirmed by appropriate tests.
- Tumor's lower edge is less than 12 cm from the anus as measured by colonoscopy, MRI, or TRUS.
- Tumor assessed as T3-4 or N+ and M0 by MRI, intracavitary ultrasound, and enhanced CT.
- ECOG physical status score of 0 or 1.
- Life expectancy of more than 1 year.
- First diagnosis with no previous anti-tumor treatment received and no chemotherapy contraindications.
- Appropriate organ function as defined by specified blood counts and liver/kidney tests.
- Able to understand and willing to provide written informed consent.
You will not qualify if you...
- Early rectal cancer (T1-2N0M0) or tumor lower margin less than 5 cm from anus requiring APR surgery.
- Multifocal colorectal cancer.
- Tumor obstruction or high risk requiring emergency surgery or stent placement.
- Unable to tolerate chemotherapy or immunotherapy.
- History of malignant tumors except certain non-invasive types.
- Acute exacerbation of major organ diseases or severe infections, ASA score > 3.
- Mental disorders, illiteracy, or language barriers preventing protocol understanding.
- Peripheral sensory neuropathy preventing oxaliplatin chemotherapy.
- Recent or ongoing glucocorticoid use beyond specified limits.
- Unable to undergo enhanced CT examination.
- Pregnancy or lactation.
- Refusal to participate.
- Other conditions deemed unsuitable by the researcher.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 12 weeks (2 or 4 cycles of 3 weeks each)
Participants receive 2 or 4 cycles of Tislelizumab combined with chemotherapy drugs Oxaliplatin and Capecitabine as neoadjuvant therapy for locally advanced rectal cancer.
Visits every 3 weeks for up to 4 cycles
Duration - Approximately 1 week
Participants undergo curative surgery (total mesorectal excision) to remove the rectal tumor, followed by immediate post-operative care.
1 hospital stay for surgery and immediate recovery
Duration - Up to 3 years
Participants are monitored for surgical complications, adverse events, and long-term outcomes including disease-free and overall survival over 3 years.
Periodic follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
Research Team
S
Sen Zhang, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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