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

ConditionEsophageal Small Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and females aged 18-75 years;

Histologically or cytologically confirmed esophageal small cell carcinoma with unresectable locally advanced / recurrent or distant metastasis

Patients who have not received systemic anti-tumor therapy

Patients with recurrence or metastasis more than 6 months after the end of adjuvant or neoadjuvant chemotherapy accompanied by radical surgery or radical chemoradiotherapy;

Disqualifiers

Known allergy to study drug or excipients, or allergy to similar drugs;

Received anti-tumor cytotoxic drug therapy, biological drug therapy (such as monoclonal antibody), immunotherapy (such as interleukin-2 or interferon) or other research drug therapy within 4 weeks before enrollment.

Received tyrosine kinase inhibitor treatment within 2 weeks before enrollment.

Patients received radiotherapy within 4 weeks or radiopharmaceuticals within 8 weeks, except for local palliative radiotherapy for bone metastases.

Trial design

Design model

Single group

Treatments tested in this trial

  • JS001

    Drug

    JS001 240mg, ivdrip, d1, Q3w

  • nab-paclitaxel

    Drug

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

  • Cisplatin

    Drug

    Cisplatin 75mg/m2, ivdrip,d1,Q3w

  • Carboplatin

    Drug

    Carboplatin AUC 5,d1,Q3w

Treatment groups

43 Participants
are divided into 1 treatment group
Group A: JS001 Combined With TPExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Objective response rate (ORR)=CR+PR

Time frame
from the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Secondary outcomes

1

Progression free survival (PFS)

PFS is the time measured from the date of initiation of treatment to the date of progression or death due to any cause, whichever occurs first.

Time frame
from the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
2

Overall survival (OS)

Overall survival (OS) is the time calculated from the initiation of treatment to date of death or censored at last follow-up.

Time frame
from the initiation date of first cycle to the date of date of death from any cause, assessed up to 2 years
3

DCR

Disease control rate (DCR) =CR+PR+SD

Time frame
from the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
4

Six-month progression-free survival rate

Six-month progression-free survival rate is the survival rate calculated at the end of the 6-month follow-up.

Time frame
from the initiation date of first cycle to six months later

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

Source ClinicalTrials.gov
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