A Clinical Study of Sintilimab as Adjuvant Therapy in Node-positive ESCC

NCT06190639 | Recruiting Phase 2

• 1 other identifier: IRB-2023-768
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of sintilimab as adjuvant therapy in node-positive esophageal squamous cell carcinoma after radical surgery without neoadjuvant therapy. The main question it aims to answer is: • Efficacy of sintilimab as adjuvant therapy Participants will receive sintilimab 200 mg once on day 1, every 21 days(Q3W).

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  From date of randomization until the date of first documented progression

  assessed up to 36months

Secondary Outcomes (1)

• Overall survival (OS)

  assessed up to 60 months

Study Arms (1)

Experimental group

EXPERIMENTAL

Drug: sintilimab

Interventions

sintilimab DRUG

200 mg once on day 1, every 21 days

Experimental group

Eligibility Criteria

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

You may qualify if:

• Signed an Informed Consent Form
• Participant type and target disease characteristics:
• ECOG PS 0-1
• Histologically confirmed T1-3N+M0 thoracic esophageal squamous cell cancer (AJCC 8th)
• can tolerate radical resection of esophageal cancer
• Resection must be performed within 4-12 weeks prior to enrollment
• All participants must be confirmed disease-free by physical and imaging examinations within 4 weeks prior to enrollment. Imaging examinations must include CT/MRI scans of the neck, chest and abdomen.
• All baseline laboratory tests will be evaluated as required and results should be available within 28 days prior to enrollment. Laboratory test values must be selected according to the following criteria (CTCAE V5.0):
• WBC ≥2000/μL;
• Neutrophils ≥1500/μL;
• Platelets ≥100 x 103/μL;
• Hemoglobin ≥9.0 g/dL;
• Creatinine: Serum creatinine ≤1.5 x above normal (ULN) or creatinine removal rate \> 50mL/ min (Cockcroft/Gault formula);
• AST ≤3 x ULN;
• ALT ≤3 x ULN;

You may not qualify if:

• Target disease
• The presence of locally advanced unresectable (regardless of stage) or metastatic disease.
• Cervical and abdominal esophageal tumors.
• Medical history and concurrent diseases
• Complete resection followed by treatment for the removed esophageal cancer (e.g., chemotherapy, targeted drugs, radiation, or biotherapy).
• Participants with ≥ grade 2 peripheral neuropathy
• Participants with active, known, or suspected autoimmune diseases. Participants with type I diabetes, hypothyroidism requiring only hormone replacement therapy, skin conditions that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or conditions that are not expected to recur without external irritants, may be enrolled.
• Glucocorticoids are required for 14 days prior to treatment (daily\>10 mg equivalent dose of prednisone) or other immunosuppressive drugs for systemic treatment.
• If there is no active autoimmune disease, inhaled or topical steroid hormones are permitted, and daily\>10 mg prednisone equivalent dose of adrenal hormone replacement therapy.
• A known history of testing positive for human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome (AIDS)
• Participants with a serious or uncontrolled medical condition.
• Radiotherapy, chemotherapy, immunotherapy, esophagectomy, esophagus-gastric junction, and gastric surgery were performed before the trial.
• Participants with severe cardiovascular or pulmonary disease, interstitial pneumonia, or a history of prior interstitial pneumonia.
• Active malignancy within the last 3 years, other than locally curable cancers that have apparently been cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
• Participants with a serious or uncontrolled medical condition

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Changchun Wang, MD

CONTACT

13606520363; wangcc@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: January 5, 2024
• Study Start: October 25, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 5, 2024

Record last verified: 2023-12

Locations

CN (1)