Clinical trial NCT06903871: Toripalimab Adjuvant Therapy in Subjects With Resected Esophageal Squamous Cell Carcinoma Who Achieved Pathological Complete Response (pCR)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma Stage II
Esophageal Squamous Cell Carcinoma Stage III
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 1-year Disease free survival rate
timeFrame: 1 year
Secondary outcomes:
measure: 1, 2, 3 years overall survival rates
timeFrame: 3 years
measure: Distant metastasis-free survival
timeFrame: 2 years
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Medical University Fourth Hospital
state: Hebei
Study officials:
References: