Albumin-bound Paclitaxel Combined With Toripalimab as First-line/Second-line Treatment of Local Advanced or Metastatic Gastric or Gastroesophageal Junction Carcinoma: A Prospective, Open-label, Single-arm Phase II Clinical Study

China Medical University, China1 site in 1 country44 target enrollmentJune 11, 2020

ConditionsGastric Carcinoma

InterventionsAlbumin-Bound Paclitaxel Toripalimab

DrugsAlbumin-Bound Paclitaxel Toripalimab

Overview

Phase: Not Applicable
Intervention: Albumin-Bound Paclitaxel
Conditions: Gastric Carcinoma
Sponsor: China Medical University, China
Enrollment: 44
Locations: 1
Primary Endpoint: PFS
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is to evaluate the efficacy and safety of Albumin-bound paclitaxel combined with Toripalimab as first-line/second-line treatment of local advanced or metastatic gastric or gastroesophageal junction carcinoma.

Registry

clinicaltrials.gov

Start Date

June 11, 2020

End Date

December 30, 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

China Medical University, China

Responsible Party

Principal Investigator

Yunpeng Liu

Director of Department of Medical Oncology

China Medical University, China

Eligibility Criteria

Inclusion Criteria

•Age:18-70 years old, female or male.
•Histopathologically diagnosed local advanced or metastatic gastric or gastroesophageal junction carcinoma, HER2 negative.
•At least one measurable lesion according to RECIST 1.
•≤1 prior line. adjuvant/neoadjuvant therapy is allowed, adjuvant/neoadjuvant therapy is considered as the first-line treatment for advanced diseases, if recurrence occurs during the treatment or within 6 months after the last treatment. prior chemotherapy combined with targeted therapy is allowed.
•ECOG performance status of 0 or
•Adequate organ and bone marrow function: ANC≥1.5×109/L, PLT≥90×109/L, HGB≥90g/L,TBil≤1.5ULN, ALT≤2.5ULN, AST≤2.5ULN, Serum Cr≤1ULN, endogenous creatinine clearance\>60ml/min (Cockcroft-Gault formula).
•The international normalized ratio (INR) ≤ 1.5 and some prothrombin time (PPT or APTT) ≤ 1.5ULN within 7 days before enrollment.
•Expected survival≥3 months.
•Signed informed consent (ICF) before enrollment.
•Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment and have a negative result and are willing to use effective and reliable contraceptive methods during and 6 months after the last treatment.

Exclusion Criteria

•History of severe allergic reactions to chimeric or humanized antibodies or fusion proteins, or known allergic to any component of Toripalimab or any component of Albumin Bound paclitaxel.
•severe hypersensitivity after previous administration of monoclonal antibody.
•≥1 prior line therapy after progression.
•Prior therapy with PD-1、PD-L1/L2、CTLA-4 antibody, or any other immunotherapy.
•A history of organ transplantation.
•Any other malignancy within 5 years excluding healed Basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of cervical or breast.
•Received anti-tumor vaccine or other immune-stimulating agents (interferon, interleukin, thymosin, immuno cell therapy, etc.) within 1 month before the first treatment.
•Symptomatic central nervous system metastases.
•Acute or chronic Active hepatitis B or hepatitis C.
•Interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, pulmonary fibrosis, severely impaired lung function and other pulmonary diseases.

Arms & Interventions

Albumin-bound Paclitaxel Combined With Toripalimab

* Albumin-bound Paclitaxel：125mg/m2 IV d1、8，Q3W * Toripalimab：240 mg，IV d1，Q3W * until disease progression, lost follow-up visit, death , unacceptable toxicity, Maximum treatment duration of Toripalimab is 24 months

Intervention: Albumin-Bound Paclitaxel

Albumin-bound Paclitaxel Combined With Toripalimab

Intervention: Toripalimab

Outcomes

Primary Outcomes

PFS

Time Frame: up to 24 months

* Progression-Free Survival * Defined as the time from first dose of study medication to the first documented disease progression per RECIST version 1.1，or death from any cause, whichever occurred first

Secondary Outcomes

ORR(up to 24 months)
DCR(up to 24 months)
OS(up to 24 months)
Change in Quality of Life(QoL)：measured by EORTC QLQ-C30 questionnaire(up to 24 months)
Adverse events(up to 24 months)