Esophageal Squamous Cell Carcinoma Stage II, Esophageal Squamous Cell Carcinoma Stage III
Conditions
Brief summary
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.
Interventions
Participants will receive toripalimab 240 mg IV once every 3 weeks. Treatment continued until disease progression, death, unacceptable toxicity, investigator decision, withdrawal, or completion of 1 years of treatment, whichever occurred first.
Sponsors
Hebei Medical University Fourth Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year Disease free survival rate | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1, 2, 3 years overall survival rates | 3 years | — |
| Distant metastasis-free survival | 2 years | — |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 1.5 years | The incidences of adverse events were calculated according to the National Cancer Institute Cancer Common Toxicity Criteria, version 5.0. |
Countries
China
Outcome results
None listed