Status:
NOT_YET_RECRUITING
Total Neoadjuvant Therapy With PD-1 for Locally Advcancer Rectal Cancer
Lead Sponsor:
The First Affiliated Hospital of University of Science and Technology of China
Conditions:
Rectal Cancer Patients
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Research Objective:To investigate the efficacy and safety of the "total neoadjuvant chemoradiotherapy combined with immunotherapy" regimen for the treatment of locally advanced rectal cancer with high...
Detailed Description
Study Title:A Single-Arm, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Total Neoadjuvant Chemoradiotherapy Combined with PD-1 Inhibitor Immunotherapy in Locally Advanced Rectal Ca...
Eligibility Criteria
Inclusion
- Pathologically confirmed rectal adenocarcinoma;
- Mid-low rectal cancer, with the lower edge of the tumor located within 12 cm from the anal verge;
- Magnetic resonance imaging (MRI) suggests locally advanced rectal cancer (T3 or T4 and M0), accompanied by at least one of the following risk factors: cT4, N2, lymphovascular invasion, involvement of the mesorectal fascia, or enlarged lateral lymph nodes (short-axis diameter \> 8 mm); patients with potentially resectable disease;
- Polymerase chain reaction (PCR) testing indicates microsatellite stability (MSS) type;
- No prior antitumor therapy, such as chemotherapy, radiotherapy, immunotherapy, or targeted therapy;
- Age between 18 and 75 years;
- ECOG Performance Status (PS) score of 0-1;
- Laboratory test results: WBC ≥ 3.5 × 10\^9/L, Hb ≥ 100 g/L, PLT ≥ 100 × 10\^9/L; normal liver and kidney function;
- Absence of severe comorbidities, and ability to tolerate surgical treatment;
- The patient or their immediate family member voluntarily agrees to participate in this study and provides written informed consent.
Exclusion
- Recurrent rectal cancer;
- Synchronous colorectal cancer;
- Pregnant or lactating patients;
- History of other malignant tumors;
- Previous antitumor therapy, including chemotherapy or radiotherapy;
- Dysfunction of vital organs such as cardiac or pulmonary insufficiency;
- History of autoimmune diseases or immunodeficiency disorders;
- Use of immunosuppressive drugs within the past year;
- Distant metastasis to organs such as the abdominal cavity, pelvis, liver, or lungs;
- Active bleeding;
- Tumor involvement of adjacent structures such as the prostate or sacral organs, making the tumor unresectable;
- Allergy to chemotherapeutic agents, immune checkpoint inhibitors, or cetuximab;
- Psychiatric disorders or lack of capacity for civil conduct, unable to provide informed consent.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07214142
Start Date
October 1 2025
End Date
December 31 2030
Last Update
October 9 2025
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