NCT04084158

A Study of Toripalimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma.

A Phase II, Randomized, Open Label, Multi-center Design Study of Toripalimab Given Before and After Concurrent Chemoradiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the efficacy and safety of Toripalimab injection (JS001) given before and after concurrent chemoradiotherapy for locally advanced esophageal squamous cell carcinoma.

Detailed description

This was a randomized, open label and multi-center phase II clinical study, which aimed to evaluate the efficacy and safety of Toripalimab injection (JS001) induction immunotherapy, plus concurrent chemoradiation, and successive Toripalimab injection (JS001) maintenance immunotherapy relative to those of standardized concurrent chemoradiation for locally advanced esophageal squamous carcinoma patients that could not receive surgical treatment or refuse surgery. All patients conforming to the inclusion and exclusion criteria were assigned as the experimental arm and control arm at the ratio of 1:1 through the stratified block randomization method. Prior to concurrent chemoradiation, the experimental arm was given anti-PD-1 antibody Toripalimab injection (JS001) for 2 cycles, concurrent chemoradiation was initiated within 4 weeks after the induction immunotherapy, then patients were evaluated within 4 weeks after the completion of concurrent chemoradiation. Those who had not achieved PD were given 2 cycles of consolidation chemotherapy, and Toripalimab injection (JS001) was continued to at most 1 year or to identified disease progression, intolerable toxicity, or the subjects asked to withdraw initiatively, or researchers judged that the subjects should withdraw from the study. The control arm was given concurrent chemoradiation alone, with sequential consolidation chemotherapy for 2 cycles. The primary endpoint is progression-free survival (PFS), Secondary end points include objective response rate (ORR), overall survival (OS), duration of response (DoR), time to distant metastasis (TTDM).

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Toripalimab injection (JS001)	Toripalimab injection (JS001) is a humanized IgG4 monoclonal antibody against the programmed death-1 (PD-1) receptor, blocks the interaction of PD-1 with its ligands and promotes T cell activation in preclinical studies.
DRUG	Paclitaxel, Albumin-Bound	Paclitaxel
RADIATION	Radiotherapy	PTV 50.4Gy/28 fractions, PGTV 61.6Gy/28 fractions, once a day, 5 days a week.
DRUG	Platinum-Based Drug	carboplatin

Timeline

• Start date: 2019-09-07
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2019-09-10
• Last updated: 2021-02-23

Locations

1 site across 1 country: China