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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
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.
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China
1-year Disease free survival rate
Time frame: 1 year
1, 2, 3 years overall survival rates
Time frame: 3 years
Distant metastasis-free survival
Time frame: 2 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The incidences of adverse events were calculated according to the National Cancer Institute Cancer Common Toxicity Criteria, version 5.0.
Time frame: 1.5 years
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