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

Shanghai Junshi Biosciences

Status and phase: Active, not recruiting; Phase 3

Conditions: Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Treatments: Combination Product: Toripalimab combined with cisplatin and paclitaxel; Combination Product: Placebo combined with cisplatin and paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT04848753

JS001-042-III-ESCC

Details and patient eligibility

About

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.

Enrollment: 663 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

663 participants in 2 patient groups, including a placebo group

Experimental Group

Active Comparator group

Description:

Toripalimab combined with cisplatin and paclitaxel

Treatment:

Combination Product: Toripalimab combined with cisplatin and paclitaxel

Control Group

Placebo Comparator group

Description:

Placebo combined with cisplatin and paclitaxel

Treatment:

Combination Product: Placebo combined with cisplatin and paclitaxel