Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma Stage II | Esophageal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Esophageal Squamous Cell Carcinoma Stage III | Esophageal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TORIPALIMAB INJECTION(JS001 ) | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Toripalimab
- interventionNames
- Drug: TORIPALIMAB INJECTION(JS001 )
- type
- NO_INTERVENTION
- label
- control
Primary outcomes (1)
- measure
- 1-year Disease free survival rate
- timeFrame
- 1 year
Secondary outcomes (3)
- measure
- 1, 2, 3 years overall survival rates
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Subjects with stage M1 resectable disease; * Received treatments for resected esophageal cancer (e.g., immunotherapy , chemotherapy, targeted therapy, radiotherapy, or biologic therapy); * 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.
References
Publications (0)
Data not yet available