NCT07543848Toborzás még nem indult2. fázis
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)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 22.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 20 (tervezett)
- Első benyújtás
- 2026. ápr. 15.
- Kezdés
- 2026. máj. 1.
- Elsődleges befejezés
- 2028. dec. 31.
- Fő szponzor
- Chongqing University Cancer Hospital
- Betegségek
- Vastagbélrák
- NCT-szám
- NCT07543848
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 20
- 2026. máj. 1. és az elsődleges befejezés (2028. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Más betegség
- Participants will be excluded if they meet any of the following criteria:
- Histology other than rectal adenocarcinoma (e.g., gastrointestinal stromal tumor, lymphoma).
- Prior pelvic radiotherapy.
- Prior treatment with PD-1, PD-L1, or CTLA-4 inhibitors.
- Known allergy to study drugs or their components.
- History of other malignancies, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma.
- Active autoimmune disease or history of autoimmune disease requiring systemic treatment.
- Immunodeficiency, including HIV infection, or history of organ transplantation.
- History of interstitial lung disease or non-infectious pneumonitis.
- Active tuberculosis infection or history of untreated tuberculosis.
- Active hepatitis B or hepatitis C infection.
- Severe cardiovascular, pulmonary, or renal disease.
- Uncontrolled hypertension despite medication.
- History of substance abuse (alcohol or drugs).
- Active uncontrolled infection.
- Use of systemic immunosuppressive therapy.
- Pregnant or breastfeeding women.
- Any condition that, in the investigator's opinion, may interfere with study participation or safety.
Kiket keres a vizsgálat
- Participants must meet all of the following criteria:
- Age 18 to 80 years, male or female.
- Histologically confirmed low rectal adenocarcinoma, with tumor located ≤5 cm from the anal verge.
- Clinical stage T1-3N0M0 according to AJCC staging criteria.
- Mismatch repair-proficient (pMMR) or microsatellite stable (MSS) tumor confirmed by immunohistochemistry or genetic testing.
- No prior anti-tumor treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, with an expected survival of at least 3 months.
- 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
- Thyroid function within normal range or adequately controlled.
- Negative pregnancy test for women of childbearing potential.
- Willingness to use effective contraception during the study and for 12 months after treatment.
- Ability to understand and willingness to sign a written informed consent form.
- Willingness and ability to comply with study procedures and follow-up.
Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Chongqing University Cancer Hospital | Chongqing | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.