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Prospective Cohort Study of Neoadjuvant Therapy With Sintilimab (PD-1 Inhibitor) Combined With Chemotherapy in Resectable ESCC

NCT06475196 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2024-06-26

No results posted yet for this study

Summary

This study is an open-label, prospective, cohort clinical study to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer. In the study, all subjects who meet the enrollment criteria will be randomized 1:1:1 to receive sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles (Group A), sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles + sintilimab for 1 cycle (Group B), sintilimab combined with platinum-containing chemotherapy for 1 cycle + sintilimab Q3W for 2 cycles (Group B) as neoadjuvant therapy, and receive radical surgery within 4-6 weeks after the completion of the last neoadjuvant therapy. Whether the subjects need adjuvant therapy and adjuvant treatment regimen after surgery are determined by the investigator, and all subjects need to complete the follow-up plan formulated by the study after surgery.

Conditions

  • Resectable Esophageal Squamous Cell Carcinoma

Interventions

DRUG

Sintilimab (PD-1 inhibitor)

to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer.

Sponsors & Collaborators

  • Tang-Du Hospital

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2024-06-20
Primary Completion
2024-06-20
Completion
2025-06-20

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 NCT06475196 on ClinicalTrials.gov