Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Phase 3Active Not RecruitingNCT04848753

Shanghai Junshi Bioscience Co., Ltd.663 enrolled

Overview

This is a randomized, placebo-controlled, multi-center, double-blinded, Phase III study to determine the efficacy and safety of patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

663

Conditions

Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Interventions

Toripalimab combined with cisplatin and paclitaxel

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Patients must fulfill all of the following inclusion criteria to be eligible for enrollment in this study: 1. Histologically confirmed locally advanced (T1N1-3M0 or T2-3N0-3M0) squamous cell carcinoma of the thoracic esophagus (per the 8th Edition of UICC-TNM Classification); 2. No suspicious cervical lymph node metastasis on cervical contrast-enhanced CT; no systemic metastasis from radiological examination; 3. Expected to be achievable to conduct R0 resection. Patients must not enter this study if any of the following exclusion criteria is fulfilled: 1. Having malignant tumors other than esophageal carcinoma within 5 years prior to randomization; 2. Combined with other inoperable condition; 3. Previous serious allergy to chemotherapeutic agents (paclitaxel or cisplatin) or any monoclonal antibody; 4. Combined with other conditions unsuitable for participation in this study as judged by investigators. Other protocol defined Inclusion/exclusion criteria could apply.

Locations (48)

The Firest Affiliated Hospital of bengbu Medical College

Bengbu, Anhui, China

Anhui provincial hospital

Hefei, Anhui, China

The Second Hospital of anhui Medical University

Hefei, Anhui, China

Jiangmen central Hospital

Jiangmen, Guangdong, China

Shenzhen people's hosptial

Shenzhen, Guangdong, China

Outcomes

Primary Outcomes

To compare IRC-assessed events-free survival (EFS) in 2 arms

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months

Secondary Outcomes

pathologically complete remission (pCR) rate

To compare the percentage of patients who achieved pCR in the 2 arms, pCR rate was defined as the percentage of subjects who achieved a complete pathological response (PCR)

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months

Investigator-assessed EFS according to RECIST v1.1

To compare Investigator-assessed events-free survival (EFS) in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months

Overall survival

To compare Overall survival in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months

1-year OS rate

To compare 1-year OS rates in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy

Time frame: from randomization to death from any cause at 1 year

3- year OS rate

To compare 3-year OS rates in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy

Time frame: from randomization to death from any cause at 3 year

5- year OS rate

To compare 5-year OS rates in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy

Time frame: from randomization to death from any cause at 5 year