Back to results

Efficacy and Safety of Toripalimab Combined With Docetaxel or Nab-paclitaxel in Patients With Advanced Gastric Cancer

Primary Purpose

Gastric Cancer Stage IV

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Toripalimab

Docetaxel

nab-paclitaxel

About this trial

This is an interventional treatment trial for Gastric Cancer Stage IV

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy and programmed death 1 inhibitor

Arm Description

Docetaxel /nab-paclitaxel in combination with Toripalimabs

Outcomes

Primary Outcome Measures

disease control rate

disease control rate，According with RECIST 1.1

Secondary Outcome Measures

progression free survival

Complication Rate

overall survival rate

Full Information

NCT ID

NCT04563975

First Posted

September 20, 2020

Last Updated

March 14, 2021

Sponsor

Tao Zhang

1. Study Identification

Unique Protocol Identification Number

NCT04563975

Brief Title

Efficacy and Safety of Toripalimab Combined With Docetaxel or Nab-paclitaxel in Patients With Advanced Gastric Cancer

Official Title

Toripalimab Combined With Docetaxel or Nab-paclitaxel in the Treatment of Advanced Gastric Cancer : a Single-arm, Open Label, Prospective Phase II Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 2, 2020 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Tao Zhang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

54 patients who meet the inclusion criteria will receive Docetaxel (60-75mg/m2, every 3 weeks) or nab-Paclitaxel （125mg/m2，every 3 weeks）combined with Toripalimab( 240mg,every 3 weeks）for 4-8 cycles until the disease progresses or intolerable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer Stage IV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy and programmed death 1 inhibitor

Arm Type

Experimental

Arm Description

Docetaxel /nab-paclitaxel in combination with Toripalimabs

Intervention Type

Drug

Intervention Name(s)

Toripalimab

Other Intervention Name(s)

JS001

Intervention Description

Toripalimab，240mg，d1，Intravenous Infusion，q3w

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

nab-paclitaxel

Other Intervention Name(s)

AI YUE

Intervention Description

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

Primary Outcome Measure Information:

Title

disease control rate

Description

disease control rate，According with RECIST 1.1

Time Frame

At 12 weeks

Secondary Outcome Measure Information:

Title

progression free survival

Description

progression free survival

Time Frame

Up to 12months

Title

Complication Rate

Description

Complication Rate

Time Frame

Up to 12months

Title

overall survival rate

Description

overall survival rate

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tao Zhang, Doctor

Phone

（+86）18971656660

1277577866@qq.com

Facility Information:

Facility Name

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

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tao Zhang, MD

Phone

027-85871982

1277577866@qq.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

13576088

Citation

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.

Results Reference

background

PubMed Identifier

27576566

Citation

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.

Results Reference

background

PubMed Identifier

24332238

Citation

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.

Results Reference

background

PubMed Identifier

29543932

Citation

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. Erratum In: JAMA Oncol. 2019 Apr 1;5(4):579.

Results Reference

background

PubMed Identifier

30506519

Citation

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.

Results Reference

background

PubMed Identifier

27745820

Citation

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.

Results Reference

background

PubMed Identifier

29880231

Citation

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.

Results Reference

background

Learn more about this trial

Efficacy and Safety of Toripalimab Combined With Docetaxel or Nab-paclitaxel in Patients With Advanced Gastric Cancer

We'll reach out to this number within 24 hrs