Clinical trial · Interventional
A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal Cancer
A Prospective, Multicenter, Single-Arm Phase II Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (cT1-3N0M0)
- 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)
This study aims to evaluate the safety and effectiveness of a combination treatment including a PD-1 inhibitor (serplulimab), oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant therapy in patients with locally advanced low rectal cancer (cT1-3N0M0). In this prospective, multicenter, single-arm phase II study, eligible patients will receive a standardized treatment regimen consisting of intratumoral injection of oncolytic virus H101, short-course radiotherapy, chemotherapy, and immunotherapy over multiple cycles. Tumor response will be assessed using imaging, endoscopy, and clinical evaluation after completion of treatment. The primary objective is to determine the 1-year clinical complete response rate. Secondary outcomes include tumor response rate, organ preservation rate, survival outcomes, and treatment safety. The results of this study may help improve treatment strategies for rectal cancer, increase the rate of complete response, and provide more opportunities for organ preservation while maintaining safety.
Conditions
Conditions (2)
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 Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncolytic Virus H101 | Biological | — | UNRESOLVED |
| Serplulimab | Drug | Serplulimab | ALIAS |
| Short-course Radiotherapy | Radiation | — | UNRESOLVED |
| XELOX Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Serplulimab + H101 + Short-course Radiotherapy + XELOX
- description
- Participants with low rectal adenocarcinoma (cT1-3N0M0) will receive total neoadjuvant therapy consisting of intratumoral oncolytic virus H101, short-course radiotherapy, serplulimab, and XELOX chemotherapy. H101 will be administered on Day 1 of Cycle 1 and Day 1 of Cycle 4. Short-course radiotherapy will be delivered during treatment. Serplulimab and XELOX chemotherapy will be administered every 3 weeks according to the study protocol. Tumor response will be assessed after completion of treatment.
- interventionNames
- Drug: Serplulimab
- Biological: Oncolytic Virus H101
- Drug: XELOX Chemotherapy
- Radiation: Short-course Radiotherapy
Primary outcomes (1)
- measure
- 1-year Clinical Complete Response Rate
- timeFrame
- 1 year after completion of treatment
- description
- Clinical complete response (cCR) is defined as no evidence of residual tumor based on digital rectal examination, endoscopy showing mucosal healing or scar, and imaging (MRI or CT) without tumor signal or metabolic activity, and no distant metastasis. The proportion of patients achieving cCR and maintaining it for at least 1 year will be evaluated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: \- Participants must meet all of the following criteria: 1. Age 18 to 80 years, male or female. 2. Histologically confirmed low rectal adenocarcinoma, with tumor located ≤5 cm from the anal verge. 3. Clinical stage T1-3N0M0 according to AJCC staging criteria. 4. Mismatch repair-proficient (pMMR) or microsatellite stable (MSS) tumor confirmed by immunohistochemistry or genetic testing. 5. No prior anti-tumor treatment. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, with an expected survival of at least 3 months. 7. Adequate organ function, including: * Absolute neutrophil count ≥1.5 × 10\^9/L * Platelet count ≥100 × 10\^9/L * Hemoglobin ≥9 g/dL * Serum albumin ≥3 g/dL * Total bilirubin ≤1.5 × upper limit of normal (ULN) * ALT and AST ≤2 × ULN * Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min * INR or PT ≤1.5 × ULN, and aPTT ≤1.5 × ULN 8. Thyroid function within normal range or adequately controlled. 9. Negative pregnancy test for women of childbearing potential. 10. Willingness to use effective contraception during the study and for 12 months after treatment. 11. Ability to understand and willingness to sign a written informed consent form. 12. Willingness and ability to comply with study procedures and follow-up. Exclusion Criteria: * Participants will be excluded if they meet any of the following criteria: 1. Histology other than rectal adenocarcinoma (e.g., gastrointestinal stromal tumor, lymphoma). 2. Prior pelvic radiotherapy. 3. Prior treatment with PD-1, PD-L1, or CTLA-4 inhibitors. 4. Known allergy to study drugs or their components. 5. History of other malignancies, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma. 6. Active autoimmune disease or history of autoimmune disease requiring systemic treatment. 7. Immunodeficiency, including HIV infection, or history of organ transplantation. 8. History of interstitial lung disease or non-infectious pneumonitis. 9. Active tuberculosis infection or history of untreated tuberculosis. 10. Active hepatitis B or hepatitis C infection. 11. Severe cardiovascular, pulmonary, or renal disease. 12. Uncontrolled hypertension despite medication. 13. History of substance abuse (alcohol or drugs). 14. Active uncontrolled infection. 15. Use of systemic immunosuppressive therapy. 16. Pregnant or breastfeeding women. 17. Any condition that, in the investigator's opinion, may interfere with study participation or safety.
References
Publications (0)
Data not yet available