Status:
NOT_YET_RECRUITING
Involve-site Radiotherapy Combined With Chemotherapy and Immunotherapy as Neoadjuvant Treatment for Locally Advanced Rectal Cancer
Lead Sponsor:
Longhao Li
Conditions:
Rectal Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Surgery is the primary treatment for rectal cancer. However, in patients with locally advanced disease, direct surgery often fails to achieve complete tumor resection. In such cases, neoadjuvant thera...
Detailed Description
This study aims to provide stronger clinical evidence for involve-site short-course radiotherapy combined with immunotherapy as a neoadjuvant treatment strategy for locally advanced rectal cancer. The...
Eligibility Criteria
Inclusion
- Voluntarily agrees to participate and provides written informed consent
- Age 18 to 75 years, male or female
- Histologically confirmed rectal adenocarcinoma
- MRI confirms that the upper margin of the tumor is ≤12 cm from the anal verge
- ECOG performance status of 0-1
- Clinical stage T3-T4 or N+ and circumferential resection margin (CRM) positive by imaging evaluation; lateral lymph nodes negative
- Immunohistochemistry or genetic testing indicates pMMR or MSS status
- Adequate organ function and bone marrow reserve
Exclusion
- Presence of distant metastasis
- Prior pelvic radiotherapy
- Chemotherapy or immunotherapy within the past 3 months
- Refusal to undergo radical surgery for rectal cancer
- Concurrent active malignancy other than rectal cancer
- Positive antinuclear antibody (ANA)
- History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis)
- Elevated troponin above the normal range
- Active tuberculosis
- Positive hepatitis B surface antigen (HBsAg) or detectable HBV DNA
- Positive for hepatitis C virus (HCV), syphilis, or HIV
- Severe comorbid conditions (e.g., serious infection, severe bone marrow suppression, psychiatric disorder) deemed unsuitable for participation by the investigator
- Pregnant or breastfeeding women
- Any other contraindications to radiotherapy, chemotherapy, or immunotherapy
Key Trial Info
Start Date :
September 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2030
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07161115
Start Date
September 19 2025
End Date
August 31 2030
Last Update
September 15 2025
Active Locations (1)
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1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016