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Esophageal Small Cell CarcinomaPhase 2NCT05173246

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

A Phase 2 study testing JS001, nab-paclitaxel and Cisplatin in people with Esophageal Small Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Small Cell Carcinoma
What is being tested?
JS001, nab-paclitaxel and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteChina
Study dates
17 Nov 2020to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.
  • HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 CPS / ml).
  • HCV antibody positive.
  • Researchers believe that it can affect the compliance of the protocol, or affect the subject to sign the informed consent(ICF), or any other disease or condition of clinical significance that is not suitable to participate in this clinical trial.
  • There are clinical symptoms or diseases that can not be well controlled, such as: (1) heart failure of NYHA grade 2 or above (2) unstable angina pectoris (3) myocardial infarction within one year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhi-da Lv, Bachelor contact

+862087342635

lvzd@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Zhi-da Lv, Bachelor, +862087342635, lvzd@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: JS001 Combined With Nab-paclitaxel and Cisplatin or Carboplatin as First-line Treatment for Unresectable or Advanced Small Cell Esophageal Carcinoma : a Prospective, Single Arm, Multicenter, Phase II Clinical 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.

Read the detailed description

Small cell esophageal carcinoma (SCCE) is a kind of malignant tumor with poor prognosis. Our previous studies 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 a common first-line treatment for ESCC. In addition, some studies have shown that PD-1 mAb combined with paclitaxel chemotherapy in esophageal cancer has better efficacy and tolerability than chemotherapy alone. JS001 is a Chinese monoclonal antibody against PD-1 for injection, 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.

Being tested
JS001, nab-paclitaxel, Cisplatin, Carboplatin
Keywords
JS001, Nab-paclitaxel and, Cisplatin, Carboplatin, Small cell esophageal carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JS001Drug

    Also called recombinant humanized anti-PD-1 monoclonal antibody for injection

    JS001 240mg, ivdrip, d1, Q3w

  • nab-paclitaxelDrug

    Also called Paclitaxel for injection (Albumin Bound)

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

  • CisplatinDrug

    Also called Cisplatin for injection

    Cisplatin 75mg/m2, ivdrip,d1,Q3w

  • CarboplatinDrug

    Also called Carboplatin for injection

    Carboplatin AUC 5,d1,Q3w

Study groups in NCT05173246
Study groupRoleWhat they receive
JS001 Combined With TPExperimentalrecombinant humanized anti-PD-1 monoclonal antibody for injection (JS001) in combination with nab-paclitaxel and cisplatin or carboplatin for injection
Receives: Drug: JS001; Drug: nab-paclitaxel; Drug: Cisplatin; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    Objective response rate (ORR)=CR+PR

    Measured: 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)

  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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: from the initiation date of first cycle to six months later

  5. One year survival rate

    One year progression-free survival rate is the survival rate calculated at the end of the 1-year follow-up.

    Measured: from the initiation date of first cycle to one year later

  6. Severe toxicity

    Treatment-related adverse events.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2021
  2. Study start17 Nov 2020
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
JS001 Combined With TP as First-line Treatment for Unresectable or Advanced Esophageal Small Cell Carcinoma
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05173246
Sponsor's protocol ID
TP+JS001 in unresectable SCCE
Status last verified
Jul 2025
First submitted
27 Dec 2021
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nishimaki T, Suzuki T, Nakagawa S, Watanabe K, Aizawa K, Hatakeyama K. Tumor spread and outcome of treatment in primary esophageal small cell carcinoma. J Surg Oncol. 1997 Feb;64(2):130-4. doi: 10.1002/(sici)1096-9098(199702)64:23.0.co;2-c.

    PubMed 9047250

  • Hosokawa A, Shimada Y, Matsumura Y, Yamada Y, Muro K, Hamaguchi T, Igaki H, Tachimori Y, Kato H, Shirao K. Small cell carcinoma of the esophagus. Analysis of 14 cases and literature review. Hepatogastroenterology. 2005 Nov-Dec;52(66):1738-41.

    PubMed 16334769

  • Chen WW, Wang F, Chen S, Wang L, Ren C, Luo HY, Wang FH, Li YH, Zhang DS, Xu RH. Detailed analysis of prognostic factors in primary esophageal small cell carcinoma. Ann Thorac Surg. 2014 Jun;97(6):1975-81. doi: 10.1016/j.athoracsur.2014.02.037. Epub 2014 Apr 14.

    PubMed 24726599

  • Gao R, Zhang Y, Wen XP, Fu J, Zhang GJ. Chemotherapy with cisplatin or carboplatin in combination with etoposide for small-cell esophageal cancer: a systemic analysis of case series. Dis Esophagus. 2014 Nov-Dec;27(8):764-9. doi: 10.1111/dote.12149. Epub 2013 Oct 10.

    PubMed 24118373

  • Mortezaee K. Immune escape: A critical hallmark in solid tumors. Life Sci. 2020 Oct 1;258:118110. doi: 10.1016/j.lfs.2020.118110. Epub 2020 Jul 19.

    PubMed 32698074

  • Jiang X, Wang J, Deng X, Xiong F, Ge J, Xiang B, Wu X, Ma J, Zhou M, Li X, Li Y, Li G, Xiong W, Guo C, Zeng Z. Role of the tumor microenvironment in PD-L1/PD-1-mediated tumor immune escape. Mol Cancer. 2019 Jan 15;18(1):10. doi: 10.1186/s12943-018-0928-4.

    PubMed 30646912

  • Fritz JM, Lenardo MJ. Development of immune checkpoint therapy for cancer. J Exp Med. 2019 Jun 3;216(6):1244-1254. doi: 10.1084/jem.20182395. Epub 2019 May 8.

    PubMed 31068379

  • O'Donnell JS, Teng MWL, Smyth MJ. Cancer immunoediting and resistance to T cell-based immunotherapy. Nat Rev Clin Oncol. 2019 Mar;16(3):151-167. doi: 10.1038/s41571-018-0142-8.

    PubMed 30523282

  • Chen L. Co-inhibitory molecules of the B7-CD28 family in the control of T-cell immunity. Nat Rev Immunol. 2004 May;4(5):336-47. doi: 10.1038/nri1349. No abstract available.

    PubMed 15122199

  • Huang J, Mo H, Zhang W, Chen X, Qu D, Wang X, Wu D, Wang X, Lan B, Yang B, Wang P, Zhang B, Yang Q, Jiao Y, Xu B. Promising efficacy of SHR-1210, a novel anti-programmed cell death 1 antibody, in patients with advanced gastric and gastroesophageal junction cancer in China. Cancer. 2019 Mar 1;125(5):742-749. doi: 10.1002/cncr.31855. Epub 2018 Dec 3.

    PubMed 30508306

  • Mo H, Huang J, Xu J, Chen X, Wu D, Qu D, Wang X, Lan B, Wang X, Xu J, Zhang H, Chi Y, Yang Q, Xu B. Safety, anti-tumour activity, and pharmacokinetics of fixed-dose SHR-1210, an anti-PD-1 antibody in advanced solid tumours: a dose-escalation, phase 1 study. Br J Cancer. 2018 Aug;119(5):538-545. doi: 10.1038/s41416-018-0100-3. Epub 2018 May 14.

    PubMed 29755117

  • Xu J, Zhang Y, Jia R, Yue C, Chang L, Liu R, Zhang G, Zhao C, Zhang Y, Chen C, Wang Y, Yi X, Hu Z, Zou J, Wang Q. Anti-PD-1 Antibody SHR-1210 Combined with Apatinib for Advanced Hepatocellular Carcinoma, Gastric, or Esophagogastric Junction Cancer: An Open-label, Dose Escalation and Expansion Study. Clin Cancer Res. 2019 Jan 15;25(2):515-523. doi: 10.1158/1078-0432.CCR-18-2484. Epub 2018 Oct 22.

    PubMed 30348638

  • Shui L, Cheng K, Li X, Shui P, Zhou X, Li J, Yi C, Cao D. Study protocol for an open-label, single-arm, phase Ib/II study of combination of toripalimab, nab-paclitaxel, and gemcitabine as the first-line treatment for patients with unresectable pancreatic ductal adenocarcinoma. BMC Cancer. 2020 Jul 9;20(1):636. doi: 10.1186/s12885-020-07126-3.

    PubMed 32646394

  • Qiu H. Safety and efficacy of toripalimab in advanced gastric cancer: A new clinical trial bringing hope for immunotherapy in gastric cancer. Cancer Commun (Lond). 2020 Apr;40(4):194-196. doi: 10.1002/cac2.12019. Epub 2020 Apr 11. No abstract available.

    PubMed 32277740

  • Lu M, Zhang P, Zhang Y, Li Z, Gong J, Li J, Li J, Li Y, Zhang X, Lu Z, Wang X, Zhou J, Peng Z, Wang W, Feng H, Wu H, Yao S, Shen L. Efficacy, Safety, and Biomarkers of Toripalimab in Patients with Recurrent or Metastatic Neuroendocrine Neoplasms: A Multiple-Center Phase Ib Trial. Clin Cancer Res. 2020 May 15;26(10):2337-2345. doi: 10.1158/1078-0432.CCR-19-4000. Epub 2020 Feb 21.

    PubMed 32086343

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JS001, nab-paclitaxel and Cisplatin in people with Esophageal Small Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhi-da Lv, Bachelor (+862087342635, lvzd@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05173246, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.

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