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

March 14, 2021 updated by: Tao Zhang

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

54

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: Tao Zhang, Doctor
  • Phone Number: （+86）18971656660
  • Email: 1277577866@qq.com

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ages 18-75
  2. Written informed consent from the patient.
  3. Pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma (GEJ).
  4. Failure of first-line chemotherapy with fluorouracil ，or adjuvant therapy with fluorouracil drugs, but the end of adjuvant treatment is less than 6 months.
  5. Measurable disease as per RECIST 1.1 criteria.
  6. Adequate organ and bone marrow functions.
  7. 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.
  8. Performance Status(ECOG) 0-2.
  9. Life expectancy >3 months.

Exclusion Criteria:

  1. First-line treatment with Taxanes- containing drugs.
  2. Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment.
  3. 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.
  4. Patients with HIV-positive.
  5. Patients with viral hepatitis (such as HBV（hepatitis B virus）, HCV（hepatitis C virus）), HBV-DNA> 2000IU/mL, and unwilling to receive antiviral treatment.
  6. 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.
  7. Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
  8. History of (non-infectious) pneumonitis that required steroids or presence of active pneumonitis.
  9. History of prior allogeneic bone marrow, stem-cell or solid organ transplantation.
  10. Clinically-significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis.
  11. 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.
  12. patients with uncontrollable seizures, or loss of insight due to mental illness.
  13. History of severe allergies or specific constitution.
  14. Participant in other clinical trials within 28 days before study treatment.

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: Chemotherapy and programmed death 1 inhibitor
Docetaxel /nab-paclitaxel in combination with Toripalimabs
Drug: Toripalimab
Toripalimab，240mg，d1，Intravenous Infusion，q3w
Other Names:
  • JS001
Drug: Docetaxel
Docetaxel，60-75mg/m2，d8 and d15，Intravenous Infusion，q3w
Other Names:
  • Taxotere
Drug: nab-paclitaxel
nab-paclitaxel，125mg/m2，d1 and d 8，Intravenous Infusion，q3w
Other Names:
  • AI YUE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease control rate
Time Frame: At 12 weeks
disease control rate，According with RECIST 1.1
At 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: Up to 12months
progression free survival
Up to 12months
Complication Rate
Time Frame: Up to 12months
Complication Rate
Up to 12months
overall survival rate
Time Frame: one year
overall survival rate
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tao Zhang

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

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)

July 2, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

May 30, 2023

Study Registration Dates

First Submitted

September 20, 2020

First Submitted That Met QC Criteria

September 20, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 14, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHZL-0236-02

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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