Clinical trial · Interventional
Total Neoadjuvant Therapy With PD-1 for Locally Advcancer Rectal Cancer
Efficacy and Safety of Total Neoadjuvant Chemoradiotherapy Combined With PD-1 Therapy for Locally Advanced Rectal Cancer With High Risk of Recurrence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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-risk features for recurrence. Study Design:A single-arm, multicenter clinical study. Study Population: Patients with locally advanced rectal cancer presenting with high-risk features for local recurrence.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TNT-immunity
- description
- 1
- interventionNames
- Drug: PD-1
Primary outcomes (1)
- measure
- pathological complete response rate
- timeFrame
- up to 2 months
- description
- the incidence of no tumor residual after the treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically confirmed rectal adenocarcinoma; 2. Mid-low rectal cancer, with the lower edge of the tumor located within 12 cm from the anal verge; 3. 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; 4. Polymerase chain reaction (PCR) testing indicates microsatellite stability (MSS) type; 5. No prior antitumor therapy, such as chemotherapy, radiotherapy, immunotherapy, or targeted therapy; 6. Age between 18 and 75 years; 7. ECOG Performance Status (PS) score of 0-1; 8. Laboratory test results: WBC ≥ 3.5 × 10\^9/L, Hb ≥ 100 g/L, PLT ≥ 100 × 10\^9/L; normal liver and kidney function; 9. Absence of severe comorbidities, and ability to tolerate surgical treatment; 10. The patient or their immediate family member voluntarily agrees to participate in this study and provides written informed consent. Exclusion Criteria: 1. Recurrent rectal cancer; 2. Synchronous colorectal cancer; 3. Pregnant or lactating patients; 4. History of other malignant tumors; 5. Previous antitumor therapy, including chemotherapy or radiotherapy; 6. Dysfunction of vital organs such as cardiac or pulmonary insufficiency; 7. History of autoimmune diseases or immunodeficiency disorders; 8. Use of immunosuppressive drugs within the past year; 9. Distant metastasis to organs such as the abdominal cavity, pelvis, liver, or lungs; 10. Active bleeding; 11. Tumor involvement of adjacent structures such as the prostate or sacral organs, making the tumor unresectable; 12. Allergy to chemotherapeutic agents, immune checkpoint inhibitors, or cetuximab; 13. Psychiatric disorders or lack of capacity for civil conduct, unable to provide informed consent.
References
Publications (0)
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