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IBI110 Combined With Sintilimab in Second-line Advanced or Metastatic Esophageal Squamous Cell Carcinoma(ESCC)

NCT06078657 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-10-12

No results posted yet for this study

Summary

This is a single-center, prospective, single-arm Phase II clinical study to evaluate the efficacy and safety of IBI110 in combination with Sintilimab in subjects with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have failed first-line treatment with PD-1 inhibitors combined with chemotherapy.

Patients who meet the inclusion criteria will be treated with IBI110 combined with Sintilimab until disease progression, death, toxicity intolerance, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of therapy for other reasons specified in the protocol. RECIST v1.1 was used for clinical tumor imaging evaluation every 6 weeks during treatment.

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)
  • PD-1 Inhibitors

Interventions

DRUG

IBI110+Sintilimab

IBI110, 200mg, intravenously on the first day of each cycle, every 3 weeks for 1 cycle (Q3W), and the maximum use time was 2 years. Sintilimab, 200mg, intravenously on the first day of each cycle, every 3 weeks as a cycle (Q3W), and the maximum use time was 2 years.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2024-10-31
Completion
2025-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06078657 on ClinicalTrials.gov