Loading clinical trials...

Efficacy and Safety of Toripalimab Combined With Docetaxel or Nab-paclitaxel in Patients With Advanced Gastric Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

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

NCT04563975•Tao Zhang

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (1)

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

Wuhan, Hubei, China

Key Dates

Start Date

July 2, 2020

Primary Completion Date

December 31, 2022

Completion Date

May 30, 2023

Last Updated

March 17, 2021

Enrollment

ESTIMATED participants

Conditions

Gastric Cancer Stage IV

Interventions

Toripalimab

DRUG

Docetaxel

DRUG

nab-paclitaxel

DRUG

Contacts

Tao Zhang, Doctor

CONTACT

（+86）18971656660 1277577866@qq.com

Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis

NCT06519591

Gastric Cancer Stage IVPeritoneal Metastases

View study

RECRUITINGPHASE1/PHASE2

Pembrolizumab, Olaparib, Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer

NCT04592211

Gastric Cancer Stage IV

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis

Pembrolizumab, Olaparib, Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer

Conversion Therapy of Sintilimab in Combination With Apatinib and Chemotherapy in Stage IV Gastric Cancer

Maintenance Treatment With S-1 in Gastric Cancer Patients