Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05173246

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

Led by Sun Yat-sen University · Updated on 2025-07-16

43

Participants Needed

1

Research Sites

319 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-sen University

Lead Sponsor

S

Shanghai Junshi Bioscience Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 18-75 years
  • Histologically or cytologically confirmed esophageal small cell carcinoma with unresectable locally advanced, recurrent, or distant metastasis
  • No prior systemic anti-tumor therapy
  • Recurrence or metastasis more than 6 months after prior adjuvant or neoadjuvant chemotherapy with radical surgery or chemoradiotherapy
  • At least one measurable lesion according to RECIST 1.1 criteria
  • ECOG performance status score of 0 or 1
  • Expected survival of 3 months or more
  • Good organ function without recent blood transfusions or hematopoietic stimulants, meeting specific blood count and liver/kidney function levels
  • Negative pregnancy test for females of childbearing age and agreement to use contraception during and for 3 months after treatment
  • Ability to understand and sign informed consent
  • Agreement to provide stored tumor tissue samples or undergo biopsy for gene testing
Not Eligible

You will not qualify if you...

  • Known allergy to the study drugs or similar drugs
  • Anti-tumor cytotoxic, biological, immunotherapy, or research drug treatment within 4 weeks before enrollment
  • Tyrosine kinase inhibitor treatment within 2 weeks before enrollment
  • Radiotherapy within 4 weeks or radiopharmaceuticals within 8 weeks, except for local palliative radiotherapy for bone metastases
  • Major surgery within 4 weeks or not fully recovered from previous surgery
  • Unresolved toxicity from prior anti-tumor therapy above certain levels, except specific mild cases
  • Symptomatic brain metastases or cancerous meningitis unless stable for 2 months and off systemic steroids for 4 weeks
  • Other active malignancies except certain controlled skin or in situ cancers
  • Active or history of autoimmune disease, excluding some fully remitted conditions
  • Prior use of PD-1, PD-L1, PD-L2, or CTLA-4 antibodies
  • Active tuberculosis under treatment or treated within one year
  • Long-term use of immunosuppressive drugs or corticosteroids above specified doses
  • Vaccination with anti-infection vaccines within 4 weeks before enrollment
  • Pregnancy or lactation
  • HIV positive
  • Positive for HBsAg and HBV DNA at specified levels
  • Positive for HCV antibody
  • Any condition affecting protocol compliance or informed consent capacity
  • Uncontrolled clinical symptoms or diseases such as heart failure NYHA grade 2 or above, unstable angina, recent myocardial infarction, or significant arrhythmias requiring treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

Z

Zhi-da Lv, Bachelor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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