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

NCT05173246 | Recruiting Phase 2

• 1 other identifier: TP+JS001 in unresectable SCCE
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

JS001; Nab-paclitaxel and; Cisplatin; Carboplatin; Small cell esophageal carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Objective response rate (ORR)=CR+PR

  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 (6)

• Progression free survival (PFS)

  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

• Overall survival (OS)

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

• DCR

  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

• Six-month progression-free survival rate

  from the initiation date of first cycle to six months later

• One year survival rate

  from the initiation date of first cycle to one year later

Study Arms (1)

JS001 Combined With TP

EXPERIMENTAL

recombinant humanized anti-PD-1 monoclonal antibody for injection (JS001) in combination with nab-paclitaxel and cisplatin or carboplatin for injection

Drug: JS001; Drug: nab-paclitaxel; Drug: Cisplatin; Drug: Carboplatin

Interventions

JS001 DRUG

JS001 240mg, ivdrip, d1, Q3w

Also known as: recombinant humanized anti-PD-1 monoclonal antibody for injection

JS001 Combined With TP

nab-paclitaxel DRUG

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

Also known as: Paclitaxel for injection (Albumin Bound)

JS001 Combined With TP

Cisplatin DRUG

Cisplatin 75mg/m2, ivdrip,d1,Q3w

Also known as: Cisplatin for injection

JS001 Combined With TP

Carboplatin DRUG

Carboplatin AUC 5,d1,Q3w

Also known as: Carboplatin for injection

JS001 Combined With TP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• With at least 1 measurable lesion according to RECIST 1.1 criteria;
• ECOG score 0-1;
• Expected survival ≥3 months;
• Good organ function (without blood transfusion, use of hematopoietic stimulating factors, or transfusion of albumin or blood products within 7 days prior to examination): 1) Platelet (PLT) count ≥75,000 /mm3; 2) Neutrophil count (ANC) ≥1,500 /mm3; 3) Hemoglobin (Hb) level ≥9.0 g/dl; 4) Total bilirubin (TBIL) level ≤1.5×ULN; 5) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level ≤2.5×ULN (≤5×ULN in case of liver metastasis); 6) Alkaline phosphatase level ≤2.5×ULN (≤5×ULN in case of liver metastasis); 7) Serum creatinine (Cr) level ≤1.5×ULN and creatinine clearance \>50 ml/min;
• Females of child bearing age must have anegative pregnancy test, and have to take contraception measures and for 3 months after the last dose
• Able to understand and willing to sign written informed consent form.
• Patients who agree to provide previously stored tumor tissue samples or perform biopsy to collect tumor tissue for gene testing.

You may not qualify if:

• 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.
• Major surgery was performed or not completely recovered from the previous surgery within 4 weeks before enrollment (the definition of major surgery refers to the level 3 and level 4 surgery specified in the administrative measures for clinical application of medical technology implemented on May 1, 2009).
• The toxicity of previous anti-tumor therapy has not recovered to CTCAE \[version 4.03\] 0-1, except for the following cases: a) lipsotrichia；b) Pigmentation;c) Peripheral neurotoxicity has recovered to \< CTCAE 2;d) The long-term toxicity caused by radiotherapy could not be recovered according to the judgment of the researchers;
• Subjects with clinically symptomatic CNS metastases and/or cancerous meningitis. The subjects who have received brain or meningeal metastasis treatment in the past, if the clinical stability has been maintained for at least 2 months, and the systemic hormone treatment has been stopped for more than 4 weeks can be included.
• Have or are currently suffering from other malignancies (except for non melanoma basal cell carcinoma of the skin, breast / cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment in the past five years).
• Subjects have any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood who have completely remission and do not need any intervention in adulthood can be included; subjects with asthma requiring bronchodilator for medical intervention can not be included).
• Previous use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell costimulation or checkpoint pathway).
• Subjects with active pulmonary tuberculosis (TB) are receiving antituberculosis treatment or received antituberculosis treatment within one year before screening.
• Patients with complications requiring long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effect (dose \> 10mg / day of prednisone or other therapeutic hormones).
• Received any anti infection vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment.
• Pregnant or lactating women.
• HIV positive.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Shanghai Junshi Bioscience Co., Ltd.: collaborator
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

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MeSH Terms

Interventions

Injections; 130-nm albumin-bound paclitaxel; Paclitaxel; Cisplatin; Carboplatin

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Officials

• Rui-hua Xu, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi-da Lv, Bachelor

CONTACT

+862087342635; lvzd@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: : Professor, Principal Investigator, President

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

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: December 29, 2021
• Study Start: November 17, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)