Conversion of Tislelizumab Combined With Chemotherapy in Unresectable Esophageal Squamous Cell Carcinoma

NCT05449483 | Unknown Phase 2

• 1 other identifier: E20220333A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Whether the introduction of immunotherapy can transform unresectable esophageal cancer into resectable, or even achieve R0 surgical resection, has not been reported yet. We plan to conduct a prospective, single-center, single-arm phase II clinical study of the safety and efficacy of tislelizumab combined with chemotherapy in the treatment of unresectable esophageal squamous cell carcinoma.

Conditions

Esophageal Squamous Cell Carcinoma by AJCC V8 Stage; Unresectable

Outcome Measures

Primary Outcomes (1)

• R0 Surgical Resection Rate .

  R0 resection rate

  1 year

Secondary Outcomes (5)

• Evaluate the rate of pathologic complete response (pCR) to the study regimen

  1 year

• Evaluate the rate of main pathologic response (MPR) to the study regimen.

  1 year

• Objective response rate (ORR)

  1 year

• Disease-free survival (DFS)

  3 years

• Overall survival (OS)

  3 years

Study Arms (1)

tislelizumab+ Paclitaxel+Cisplatin

EXPERIMENTAL

Paclitaxel 135mg/m2 , D1; Cisplatin 80mg/m2, D1; tislelizumab 200mg D2 ; totally 2-4 cycles

Drug: tislelizumab+ Paclitaxel + Cisplatin

Interventions

tislelizumab+ Paclitaxel + Cisplatin DRUG

tislelizumab combined with chemotherapy

Also known as: conversion therapy

tislelizumab+ Paclitaxel+Cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed esophageal squamous cell carcinoma;
• Unresectable cT4a/N3(stage ⅣA) (AJCC 8 TNM classification);
• Have a performance status of 0 or 1 on the ECOG Performance Scale;
• Age 18-75 years old, both men and women;
• Be willing and able to provide written informed consent/assent for the trial;
• Demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation;
• Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours before receiving the study medication's first dose. If the urine test is positive or cannot be confirmed as unfavorable, a serum pregnancy test will be required;
• Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly acquired is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.

You may not qualify if:

• Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer;
• Ineligibility or contraindication for esophagectomy;
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs);
• Has severe hypersensitivity and adverse events (≥Grade 3) to any PD-1/PD-L1 inhibitors.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Hongjing Jiang

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Interventions

Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Hongjing Jiang, MD，phD

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongjing Jiang, MD，phD

CONTACT

18622221069; jianghongjing@tmu.edu.cn

Xiaobin Shang, MD，phD

CONTACT

18622221071; shangxiaobin@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 8, 2022
• Study Start: May 11, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2025
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)