NCT04563975

Brief Summary

The single arm clinical study is to evaluate the efficacy and safety of an anti-PD-1 antibody (Toripalimab) combined with chemotherapy (docetaxel or nab-Paclitaxel) in patients with advanced gastric cancer who failed first-line treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

September 20, 2020

Last Update Submit

March 14, 2021

Conditions

Gastric Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

  • disease control rate

    disease control rate，According with RECIST 1.1

    At 12 weeks

Secondary Outcomes (3)

  • progression free survival

    Up to 12months

  • Complication Rate

    Up to 12months

  • overall survival rate

    one year

Study Arms (1)

Chemotherapy and programmed death 1 inhibitor

EXPERIMENTAL

Docetaxel /nab-paclitaxel in combination with Toripalimabs

Drug: ToripalimabDrug: DocetaxelDrug: nab-paclitaxel

Interventions

ToripalimabDRUG

Toripalimab，240mg，d1，Intravenous Infusion，q3w

Also known as: JS001
Chemotherapy and programmed death 1 inhibitor
DocetaxelDRUG

Docetaxel，60-75mg/m2，d8 and d15，Intravenous Infusion，q3w

Also known as: Taxotere
Chemotherapy and programmed death 1 inhibitor
nab-paclitaxelDRUG

nab-paclitaxel，125mg/m2，d1 and d 8，Intravenous Infusion，q3w

Also known as: AI YUE
Chemotherapy and programmed death 1 inhibitor

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18-75
  • Written informed consent from the patient.
  • Pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma (GEJ).
  • Failure of first-line chemotherapy with fluorouracil ，or adjuvant therapy with fluorouracil drugs, but the end of adjuvant treatment is less than 6 months.
  • Measurable disease as per RECIST 1.1 criteria.
  • Adequate organ and bone marrow functions.
  • Female subjects should agree to use a medically approved effective contraceptive during the study period and for up to 6 months after the study，and must undergo a serum-negative pregnancy test within 72hours before starting the study drug, and out of lactation;male subjects should agree to use medically approved methods of contraception during the study period and within 6 months after the end of the study period.
  • Performance Status(ECOG) 0-2.
  • Life expectancy \>3 months.

You may not qualify if:

  • First-line treatment with Taxanes- containing drugs.
  • Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment.
  • Have received immunosuppressive drugs within 2 weeks before starting the study drug, excluding local glucocorticoids or systemic glucocorticoids\<10 mg/day prednisone or other glucocorticoids of equivalent dose.
  • Patients with HIV-positive.
  • Patients with viral hepatitis (such as HBV（hepatitis B virus）, HCV（hepatitis C virus）), HBV-DNA\> 2000IU/mL, and unwilling to receive antiviral treatment.
  • History of clinically-significant cardiovascular disease ，Liver diseases such as liver cirrhosis decompensated liver disease, and chronic active hepatitis; poorly controlled diabetes (fasting blood glucose (FBG)\>10mmol/L); urine routine indicates urine protein ≥++, and 24-hour urine protein quantitative \> 1.0g.
  • Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
  • History of (non-infectious) pneumonitis that required steroids or presence of active pneumonitis.
  • History of prior allogeneic bone marrow, stem-cell or solid organ transplantation.
  • Clinically-significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis.
  • History of malignant tumors (except for skin basal cell carcinoma and cervical carcinoma in situ treatment with tumor-free survival for more than 3 years.
  • patients with uncontrollable seizures, or loss of insight due to mental illness.
  • History of severe allergies or specific constitution.
  • Participant in other clinical trials within 28 days before study treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (7)

  • HAENSZEL W. Variation in incidence of and mortality from stomach cancer, with particular reference to the United States. J Natl Cancer Inst. 1958 Aug;21(2):213-62. No abstract available.

    PMID: 13576088BACKGROUND

  • Ter Veer E, Haj Mohammad N, van Valkenhoef G, Ngai LL, Mali RMA, Anderegg MC, van Oijen MGH, van Laarhoven HWM. The Efficacy and Safety of First-line Chemotherapy in Advanced Esophagogastric Cancer: A Network Meta-analysis. J Natl Cancer Inst. 2016 Aug 30;108(10). doi: 10.1093/jnci/djw166. Print 2016 Oct.

    PMID: 27576566BACKGROUND

  • Ford HE, Marshall A, Bridgewater JA, Janowitz T, Coxon FY, Wadsley J, Mansoor W, Fyfe D, Madhusudan S, Middleton GW, Swinson D, Falk S, Chau I, Cunningham D, Kareclas P, Cook N, Blazeby JM, Dunn JA; COUGAR-02 Investigators. Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial. Lancet Oncol. 2014 Jan;15(1):78-86. doi: 10.1016/S1470-2045(13)70549-7. Epub 2013 Dec 10.

    PMID: 24332238BACKGROUND

  • Fuchs CS, Doi T, Jang RW, Muro K, Satoh T, Machado M, Sun W, Jalal SI, Shah MA, Metges JP, Garrido M, Golan T, Mandala M, Wainberg ZA, Catenacci DV, Ohtsu A, Shitara K, Geva R, Bleeker J, Ko AH, Ku G, Philip P, Enzinger PC, Bang YJ, Levitan D, Wang J, Rosales M, Dalal RP, Yoon HH. Safety and Efficacy of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Clinical KEYNOTE-059 Trial. JAMA Oncol. 2018 May 10;4(5):e180013. doi: 10.1001/jamaoncol.2018.0013. Epub 2018 May 10.

    PMID: 29543932BACKGROUND

  • Kato K, Satoh T, Muro K, Yoshikawa T, Tamura T, Hamamoto Y, Chin K, Minashi K, Tsuda M, Yamaguchi K, Machida N, Esaki T, Goto M, Komatsu Y, Nakajima TE, Sugimoto N, Yoshida K, Oki E, Nishina T, Tsuji A, Fujii H, Kunieda K, Saitoh S, Omuro Y, Azuma M, Iwamoto Y, Taku K, Fushida S, Chen LT, Kang YK, Boku N. A subanalysis of Japanese patients in a randomized, double-blind, placebo-controlled, phase 3 trial of nivolumab for patients with advanced gastric or gastro-esophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2). Gastric Cancer. 2019 Mar;22(2):344-354. doi: 10.1007/s10120-018-0899-6. Epub 2018 Dec 1.

    PMID: 30506519BACKGROUND

  • Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508. doi: 10.1016/S1470-2045(16)30498-3. Epub 2016 Oct 10.

    PMID: 27745820BACKGROUND

  • Shitara K, Ozguroglu M, Bang YJ, Di Bartolomeo M, Mandala M, Ryu MH, Fornaro L, Olesinski T, Caglevic C, Chung HC, Muro K, Goekkurt E, Mansoor W, McDermott RS, Shacham-Shmueli E, Chen X, Mayo C, Kang SP, Ohtsu A, Fuchs CS; KEYNOTE-061 investigators. Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial. Lancet. 2018 Jul 14;392(10142):123-133. doi: 10.1016/S0140-6736(18)31257-1. Epub 2018 Jun 4.

    PMID: 29880231BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

toripalimabDocetaxel130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Central Study Contacts

Tao Zhang, Doctor

CONTACT

（+86）189716566601277577866@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

September 20, 2020

First Posted

September 25, 2020

Study Start

July 2, 2020

Primary Completion

December 31, 2022

Study Completion

May 30, 2023

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)