- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05173246
JS001 Combined With TP as First-line Treatment for Unresectable or Advanced Small Cell Esophageal Carcinoma
June 24, 2023 updated by: Ruihua Xu, Sun Yat-sen University
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, Single Center, 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, single center, 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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, single center, 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.
Study Type
Interventional
Enrollment (Estimated)
43
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhi-da Lv, Bachelor
- Phone Number: +862087342635
- Email: lvzd@sysucc.org.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-Sen University Cancer Center
-
Contact:
- Zhi-da Lv, Bachelor
- Phone Number: +862087342635
- Email: lvzd@sysucc.org.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: JS001 Combined With TP
recombinant humanized anti-PD-1 monoclonal antibody for injection (JS001) in combination with nab-paclitaxel and cisplatin or carboplatin for injection
|
JS001 240mg, ivdrip, d1, Q3w
Other Names:
nab-paclitaxel 220 mg/m2,ivdrip, d1,d8,Q3w
Other Names:
Cisplatin 75mg/m2, ivdrip,d1,Q3w
Other Names:
Carboplatin AUC 5,d1,Q3w
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival (PFS)
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
|
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.
|
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)
Time Frame: from the initiation date of first cycle to the date of date of death from any cause, assessed up to 2 years
|
Overall survival (OS) is the time calculated from the initiation of treatment to date of death or censored at last follow-up.
|
from the initiation date of first cycle to the date of date of death from any cause, assessed up to 2 years
|
DCR
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
|
Disease control rate (DCR) =CR+PR+SD
|
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
Time Frame: from the initiation date of first cycle to six months later
|
Six-month progression-free survival rate is the survival rate calculated at the end of the 6-month follow-up.
|
from the initiation date of first cycle to six months later
|
One year survival rate
Time Frame: from the initiation date of first cycle to one year later
|
One year progression-free survival rate is the survival rate calculated at the end of the 1-year follow-up.
|
from the initiation date of first cycle to one year later
|
Severe toxicity
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
|
Treatment-related adverse events.
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rui-hua Xu, PhD, Sun Yat-sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Antonia SJ, Lopez-Martin JA, Bendell J, Ott PA, Taylor M, Eder JP, Jager D, Pietanza MC, Le DT, de Braud F, Morse MA, Ascierto PA, Horn L, Amin A, Pillai RN, Evans J, Chau I, Bono P, Atmaca A, Sharma P, Harbison CT, Lin CS, Christensen O, Calvo E. Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial. Lancet Oncol. 2016 Jul;17(7):883-895. doi: 10.1016/S1470-2045(16)30098-5. Epub 2016 Jun 4. Erratum In: Lancet Oncol. 2016 Jul;17 (7):e270. Lancet Oncol. 2019 Feb;20(2):e70.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Wang F, Liu DB, Zhao Q, Chen G, Liu XM, Wang YN, Su H, Qin YR, He YF, Zou QF, Liu YH, Lin YE, Liu ZX, Bei JX, Xu RH. The genomic landscape of small cell carcinoma of the esophagus. Cell Res. 2018 Jul;28(7):771-774. doi: 10.1038/s41422-018-0039-1. Epub 2018 May 4. No abstract available.
- Ajani JA, D'Amico TA, Bentrem DJ, Chao J, Corvera C, Das P, Denlinger CS, Enzinger PC, Fanta P, Farjah F, Gerdes H, Gibson M, Glasgow RE, Hayman JA, Hochwald S, Hofstetter WL, Ilson DH, Jaroszewski D, Johung KL, Keswani RN, Kleinberg LR, Leong S, Ly QP, Matkowskyj KA, McNamara M, Mulcahy MF, Paluri RK, Park H, Perry KA, Pimiento J, Poultsides GA, Roses R, Strong VE, Wiesner G, Willett CG, Wright CD, McMillian NR, Pluchino LA. Esophageal and Esophagogastric Junction Cancers, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 Jul 1;17(7):855-883. doi: 10.6004/jnccn.2019.0033.
- Yardley DA. nab-Paclitaxel mechanisms of action and delivery. J Control Release. 2013 Sep 28;170(3):365-72. doi: 10.1016/j.jconrel.2013.05.041. Epub 2013 Jun 11.
- Paz-Ares L, Vicente D, Tafreshi A, Robinson A, Soto Parra H, Mazieres J, Hermes B, Cicin I, Medgyasszay B, Rodriguez-Cid J, Okamoto I, Lee S, Ramlau R, Vladimirov V, Cheng Y, Deng X, Zhang Y, Bas T, Piperdi B, Halmos B. A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. J Thorac Oncol. 2020 Oct;15(10):1657-1669. doi: 10.1016/j.jtho.2020.06.015. Epub 2020 Jun 26.
- Shui L, Cheng K, Li X, Shui P, Li S, Peng Y, Li J, Guo F, Yi C, Cao D. Durable Response and Good Tolerance to the Triple Combination of Toripalimab, Gemcitabine, and Nab-Paclitaxel in a Patient With Metastatic Pancreatic Ductal Adenocarcinoma. Front Immunol. 2020 Jun 19;11:1127. doi: 10.3389/fimmu.2020.01127. eCollection 2020.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 17, 2020
Primary Completion (Estimated)
November 17, 2024
Study Completion (Estimated)
November 17, 2025
Study Registration Dates
First Submitted
December 27, 2021
First Submitted That Met QC Criteria
December 27, 2021
First Posted (Actual)
December 29, 2021
Study Record Updates
Last Update Posted (Actual)
June 27, 2023
Last Update Submitted That Met QC Criteria
June 24, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Head and Neck Neoplasms
- Esophageal Diseases
- Lung Neoplasms
- Carcinoma
- Small Cell Lung Carcinoma
- Esophageal Neoplasms
- Carcinoma, Small Cell
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
- Cisplatin
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- TP+JS001 in unresectable SCCE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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