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

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

JS001 Combined With TP as First-line Treatment for Unresectable or Advanced Small Cell Esophageal Carcinoma (NCT05173246) is a Phase 2 interventional studying Esophageal Small Cell Carcinoma, sponsored by Sun Yat-sen University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Esophageal Small Cell Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 43 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Males and females aged 18-75 years; 2. diagnosed by tissue sample (biopsy-confirmed) esophageal small cell carcinoma with unresectable locally advanced / recurrent or distant metastasis 3. Patients who have not received systemic anti-tumor therapy 4. Patients with recurrence or metastasis more than 6 months after the end of adjuvant or neoadjuvant chemotherapy accompanied by radical surgery or radical chemoradiotherapy; 5. With at least 1 measurable lesion according to RECIST 1.1 criteria; 6. ECOG score 0-1; 7. Expected survival ≥3 months; 8. 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; 9. Females of child bearing age must have anegative pregnancy test, and have to take contraception measures and for 3 months after the last dose 10. Able to understand and willing to sign written willing to sign a consent form form. 11. Patients who agree to provide previously stored tumor tissue samples or perform biopsy to collect tumor tissue for gene testing. Who Should NOT Join This Trial: 1. Known allergy to study drug or excipients, or allergy to similar drugs; 2. 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. 3. Received tyrosine kinase inhibitor treatment within 2 weeks before enrollment. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Males and females aged 18-75 years; 2. Histologically or cytologically confirmed esophageal small cell carcinoma with unresectable locally advanced / recurrent or distant metastasis 3. Patients who have not received systemic anti-tumor therapy 4. Patients with recurrence or metastasis more than 6 months after the end of adjuvant or neoadjuvant chemotherapy accompanied by radical surgery or radical chemoradiotherapy; 5. With at least 1 measurable lesion according to RECIST 1.1 criteria; 6. ECOG score 0-1; 7. Expected survival ≥3 months; 8. 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; 9. Females of child bearing age must have anegative pregnancy test, and have to take contraception measures and for 3 months after the last dose 10. Able to understand and willing to sign written informed consent form. 11. Patients who agree to provide previously stored tumor tissue samples or perform biopsy to collect tumor tissue for gene testing. Exclusion Criteria: 1. Known allergy to study drug or excipients, or allergy to similar drugs; 2. 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. 3. Received tyrosine kinase inhibitor treatment within 2 weeks before enrollment. 4. Patients received radiotherapy within 4 weeks or radiopharmaceuticals within 8 weeks, except for local palliative radiotherapy for bone metastases. 5. 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). 6. 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; 7. 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. 8. 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). 9. 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). 10. 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). 11. Subjects with active pulmonary tuberculosis (TB) are receiving antituberculosis treatment or received antituberculosis treatment within one year before screening. 12. 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). 13. Received any anti infection vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment. 14. Pregnant or lactating women. 15. HIV positive. 16. HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 CPS / ml). 17. HCV antibody positive. 18. 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. 19. 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.

Treatments Being Tested

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05173246), the sponsor (Sun Yat-sen University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05173246 clinical trial studying?

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 unre… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05173246?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05173246?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05173246. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05173246. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.