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

Tao Zhang1 site in 1 country54 target enrollmentJuly 2, 2020

ConditionsGastric Cancer Stage IV

InterventionsToripalimab Docetaxel nab-paclitaxel

DrugsToripalimab Docetaxel nab-paclitaxel

Overview

Phase: Phase 2
Intervention: Toripalimab
Conditions: Gastric Cancer Stage IV
Sponsor: Tao Zhang
Enrollment: 54
Locations: 1
Primary Endpoint: disease control rate
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2, 2020

End Date

May 30, 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tao Zhang

Responsible Party

Sponsor Investigator

Principal Investigator

Tao Zhang

Chief Physician

Wuhan Union Hospital, China

Eligibility Criteria

Inclusion Criteria

•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-
•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.