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

NCT06161909 | Not Yet Recruiting Phase 3

• 1 other identifier: POSLS-union02
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma Thoracic Stage II; Esophageal Squamous Cell Carcinoma Thoracic Stage III; Esophageal Squamous Cell Carcinoma Thoracic Stage IV

Keywords

Esophageal cancer; Surgery; Immunotherapy; Prognosis

Outcome Measures

Primary Outcomes (1)

• disease-free survival (DFS)

  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.

  2 years

Secondary Outcomes (3)

• postoperative overall survival (OS)

  2 years

• 1, 2, and 3-year postoperative OS

  1, 2, and 3-year

• recurrent metastasis pattern

  two-year period

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: sintilimab

Group B

NO INTERVENTION

Close observation.

Interventions

sintilimab DRUG

200mg fixed dose Q3W,1 year

Group A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent prior to the implementation of any trial-related processes;
• Male or female, ≥18 years of age or ≤75 years of age;
• Pathologically confirmed ESCC in the thoracic segment;
• 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);
• 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;
• Postoperative pathological assessment of non-pCR, and residual tumor in the primary tumor focus or regional lymph nodes.

You may not qualify if:

• 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);
• Serious surgical complications after resection of esophageal cancer with reference to Clavien-Dindo classification \> 3;
• Individuals with a history of allergy or hypersensitivity to components of the study drug or severe hypersensitivity to any monoclonal antibody;
• 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;
• 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;
• Women who are pregnant or breastfeeding;
• Presence of any serious or uncontrollable systemic disease.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian

Fujian, 350100, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Maohui Chen

  Fujian Medical University Union Hospital

  STUDY CHAIR

Central Study Contacts

Maohui Chen

CONTACT

+8618659181171; 757860733@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 8, 2023
• Study Start: January 10, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: December 8, 2023

Record last verified: 2023-10

Locations

CN (1)