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JS001 Combined With TP as First-line Treatment for Unresectable or Advanced Small Cell Esophageal Carcinoma

NCT05173246 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-07-16

No results posted yet for this study

Summary

Small cell esophageal carcinoma (SCCE) is a kind of malignant tumor with poor prognosis. Our study found that the mutation spectrum and somatic CNV spectrum of SCCE were similar to those of esophageal squamous cell carcinoma (ESCC). Paclitaxel combined with cisplatin or carboplatin is the first-line treatment for ESCC. JS001 is a Chinese anti-PD-1 monoclonal antibody, which has been approved for the treatment of melanoma. This is a prospective, single arm, multicenter, phase II clinical trial of JS001 combined with nab-paclitaxel and cisplatin or carboplatin in the first-line treatment of unresectable or advanced SCCE. Aim to evaluate the safety and efficacy of this regimen in patients with unresectable or advanced SCCE.

Conditions

  • Esophageal Small Cell Carcinoma

Interventions

DRUG

JS001

JS001 240mg, ivdrip, d1, Q3w

DRUG

nab-paclitaxel

nab-paclitaxel 220 mg/m2,ivdrip, d1,d8,Q3w

DRUG

Cisplatin

Cisplatin 75mg/m2, ivdrip,d1,Q3w

DRUG

Carboplatin

Carboplatin AUC 5,d1,Q3w

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    collaborator OTHER

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Rui-hua Xu, PhD · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05173246 on ClinicalTrials.gov