NCT06903871Not yet recruitingPhase 2
Toripalimab Adjuvant Therapy in Subjects With Resected Esophageal Squamous Cell Carcinoma Who Achieved Pathological Complete Response (pCR)
A Prospective, Randomized, Open-label, Controlled Clinical Study Comparing Toripalimab Adjuvant Therapy Versus Clinical Observation in Subjects With Resected Esophageal Squamous Cell Carcinoma Who Achieved Pathological Complete Response (pCR)
Source: ClinicalTrials.gov · Last updated 1 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to assess the 1-year DFS rate of toripalimab adjuvant therapy in participants with resected esophageal squamous cell carcinoma (ESCC) who achieved pCR. The main questions it aims to answer are: * The toripalimab adjuvant therapy could impove the 1-year DFS rate in participants with rescted ESCC who achieved pCR? * Is this treatment regimen safe? Researchers will compare toripalimab adjuvant therapy to clinical observation to see if toripalimab could improve the 1-year DFS rate. Participants will receive toripalimab 240 mg IV once every 3 weeks for one year or clinical observation.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 190 (estimated)
- First submitted
- 21 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 1 Mar 2029
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06903871
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 190
- From 1 Apr 2025 to the primary completion date, 1 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received treatments for resected esophageal cancer (e.g., immunotherapy , chemotherapy, targeted therapy, radiotherapy, or biologic therapy);
Other illness
- Subjects with stage M1 resectable disease；
- Known to be allergic, highly sensitive or intolerable to research-related drugs or excipient
- In the past 5 years, there were other malignant tumors, melanoma skin cancer or ervical carcinoma in situ were excepted.
Who the study is looking for
- Stage II or III esophageal cancer with histologically confirmed predominant squamous cell carcinoma at initial diagnosis;
- Subjects must complete preoperative neoadjuvant therapy (unlimited treatment regimen) before being assigned to treatment and then undergo surgery;
- Subjects must undergo complete resection (R0), be surgically determined to be disease-free and have a negative margin on the resected specimen, defined as no viable tumor within 1 mm of the proximal, distal, or surrounding resection boundary;
- Subjects must have no residual pathology, the primary tumor is pCR, and the pathology report of the resected lymph nodes is ypN0;
- ECOG performance status of 0 or 1;
- The laboratory test meet the following requirements:
- Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function：Total bilirubin ≤ 1.5 x ULN；AST and ALT ≤ 3 x ULN Renal function：Cr ≤ 1.5 x ULN，Ccr ≥ 50 ml/min.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hebei Medical University Fourth Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.