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

June 20, 2024 updated by: Tang-Du Hospital

The Prospective Cohort Study of Neoadjuvant Therapy With Sintilimab (PD-1 Inhibitor) Combined With Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Tangdu Hospital of the Fourth Millitary Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Preoperative gastroscopy showed that the main body of the tumor was located.
  2. Patients with potentially resectable esophageal cancer evaluated by preoperative imaging (chest contrast-enhanced CT, head CT or MRI, abdominal B-ultrasound, PET/CT), and the potentially resectable patients refer to the 2018 edition of the Diagnosis and Treatment Standards for Esophageal Cancer formulated by the National Health and Wellness Commission, defined as patients with esophageal cancer stage T2-3, N0/N+, M0 or T4a, N0-1, M0 (8th edition AJCC stage in 2017).
  3. Signed informed consent and met all the inclusion criteria of this study. 4）aged 18~75 years old 5）ECOG PS score of 0-1;

Exclusion Criteria:

  1. prior treatment with immune checkpoint inhibitors, including but not limited to anti-CTLA-4, anti-PD-1 and anti-PD-L1 therapeutic antibodies, and OX-40;
  2. .previous systemic therapy;
  3. current participation in an interventional clinical trial or receipt of another investigational drug or medical intervention within 4 weeks;
  4. presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction (or other factors affecting the absorption of oral medications such as inability to swallow, nausea and vomiting, abnormal physiologic function, malabsorption syndrome, etc.) that require clinical intervention
  5. the presence of any signs or history of bleeding constitution; the presence of unhealed wounds, ulcers, or fractures in patients who have experienced any bleeding or hemorrhagic event ≥ CTCAE Grade 3 within 4 weeks prior to enrollment; -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles
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.
Group B
sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles + sintilimab for 1 cycle
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.
Group C
sintilimab combined with platinum-containing chemotherapy for 1 cycle + sintilimab Q3W for 2 cycles
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete pathologic response (pCR)
Time Frame: 3 mouths
no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment.
3 mouths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 20, 2024

Primary Completion (Estimated)

June 20, 2024

Study Completion (Estimated)

June 20, 2025

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT202405-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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