Postoperative Immune Maintenance Therapy for Esophageal Squamous Cell Carcinoma After Radical Resection

Phase 3

Not yet recruiting

• Conditions: Esophageal Squamous Cell Carcinoma Thoracic Stage IV; Esophageal Squamous Cell Carcinoma Thoracic Stage II; Esophageal Squamous Cell Carcinoma Thoracic Stage III
• Interventions: Drug: sintilimab

• Registration Number: NCT06161909
• Lead Sponsor: Fujian Medical University Union Hospital

Brief Summary

Esophageal cancer (EC) is one of the most common malignant tumors of the digestive tract in human beings. Most cases of EC are initially diagnosed in an advanced stage of the disease. Considering the lack of effective adjuvant therapies after surgery for locally advanced esophageal squamous carcinoma. And with the encouraging preliminary results of PD-1 inhibitors in advanced esophageal squamous cell carcinoma (ESCC), postoperative adjuvant immunotherapy for esophageal squamous carcinoma seems to be feasible. The main objective of this study was the efficacy of postoperative adjuvant therapy with sintilimab in patients with ESCC radically resected after neoadjuvant chemoimmunotherapy.

Detailed Description

sophageal cancer (EC) is one of the most common malignant tumors of the digestive tract in human beings. Most cases of EC are initially diagnosed in an advanced stage of the disease. Considering the lack of effective adjuvant therapies after surgery for locally advanced esophageal squamous carcinoma. And with the encouraging preliminary results of PD-1 inhibitors in advanced esophageal squamous cell carcinoma (ESCC), postoperative adjuvant immunotherapy for esophageal squamous carcinoma seems to be feasible. The main objective of this study was the efficacy of postoperative adjuvant therapy with sintilimab in patients with ESCC radically resected after neoadjuvant chemoimmunotherapy.

All participants who meet the inclusion criteria will be enrolled after signing the informed consent form. A total of 400 patients are to be recruited for the study. 400 subjects were randomly assigned to the two treatment groups. Group A: Postoperative adjuvant sintilimab 200mg fixed dose Q3W, immunotherapy will be administered for a total of 1 year. Group B: Close observation. The primary endpoint is disease-free survival (DFS). The secondary endpoints are postoperative overall survival (OS); 1, 2, and 3-year postoperative OS rates; recurrent metastasis pattern (local recurrence or distant metastasis).

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-11-30
• Last Update Submitted: 2023-11-30
• Study First Posted: 2023-12-08
• Last Update Posted: 2023-12-08
• Study Start: 2024-01-10
• Primary Completion: 2025-12
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Signed written informed consent prior to the implementation of any trial-related processes;
2. Male or female, ≥18 years of age or ≤75 years of age;
3. Pathologically confirmed ESCC in the thoracic segment;
4. Received 2-4 cycles of neoadjuvant chemoimmunotherapy and assessed by imaging as CR or PR (clinical staging of cT1b-T2,N+ or cT3-T4a,ANY N) (8th edition UICC/AJCC TNM staging);
5. Underwent radical surgery, and had negative surgical margins confirmed pathologically after surgery (R0), defined as the absence of squamous carcinoma cells from the proximal, distal, or peripheral resection borders of esophageal carcinoma;
6. Postoperative pathological assessment of non-pCR, and residual tumor in the primary tumor focus or regional lymph nodes.

Exclusion Criteria

1. Patients with an untreated diagnosis of another malignancy within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection);
2. Serious surgical complications after resection of esophageal cancer with reference to Clavien-Dindo classification > 3;
3. Individuals with a history of allergy or hypersensitivity to components of the study drug or severe hypersensitivity to any monoclonal antibody;
4. All toxicities (other than nephropathy, neuropathy, hearing loss, alopecia, and fatigue) attributable to prior antitumor therapy (preoperative induction therapy) must have recovered to baseline levels or Grade 1 (CTCAE Version 5.0) prior to administration of study drug;
5. Received systemic therapy with a proprietary medicine with an antitumor indication or an immunomodulatory drug (including thymidine, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks prior to the first dose;
6. Women who are pregnant or breastfeeding;
7. Presence of any serious or uncontrollable systemic disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	sintilimab	Postoperative adjuvant sintilimab 200mg fixed dose Q3W, immunotherapy will be administered for a total of 1 year.

Primary Outcome Measures

Name	Time	Method
disease-free survival (DFS)	2 years	disease-free survival (the time from the date of randomization to the first date of disease recurrence or death, whichever occurred first, before subsequent anticancer therapy).DFS for 400 participants.

Secondary Outcome Measures

Name	Time	Method
1, 2, and 3-year postoperative OS	1, 2, and 3-year	1, 2, and 3-year postoperative OS for 400 participants.
recurrent metastasis pattern	two-year period	recurrent metastasis pattern (local recurrence or distant metastasis) for 400 participants.
postoperative overall survival (OS)	2 years	The postoperative overall survival (OS) was defined as the time from primary tumor resection (surgical date) to last follow-up or death.OS for 400 participants.

Trial Locations

Locations (1)

Fujian; 🇨🇳 Fujian, China