A Multicenter, Randomized, Controlled Phase II Clinical Study of Comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in Second-line or Above Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 site in 1 country100 target enrollmentJanuary 13, 2023

ConditionsGastric Adenocarcinoma Adenocarcinoma of Gastroesophageal Junction

InterventionsDocetaxel for injection (Albumin-bound)Taxotere

DrugsDocetaxel for injection (Albumin-bound)Taxotere

Overview

Phase: Phase 2
Intervention: Docetaxel for injection (Albumin-bound)
Conditions: Gastric Adenocarcinoma
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Enrollment: 100
Locations: 1
Primary Endpoint: Progression-Free-Survival (PFS)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is a multicenter, randomized, controlled clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.

Detailed Description

One hundred patients with locally advanced or metastatic gastric adenocarcinoma or gastric esophageal junction adenocarcinoma will be randomly assigned to the test group or the control group. All patients will receive Docetaxel for injection (Albumin-bound) or Taxotere for treatment until disease progression. Regular visits and imaging examinations will be conducted to compare the efficacy and safety of the two groups.

Registry

clinicaltrials.gov

Start Date

January 13, 2023

End Date

December 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age: 18-75 (inclusive) (Whichever is on the day of signing the informed consent form).
•Willing to sign the informed consent form, willing and able to follow the program to accept visits, treatment and laboratory tests.
•Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by histology or cytology.
•Locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction after receiving at least first-line systematic treatment (defined as platinum/fluorouracil containing dual drug chemotherapy, with or without immunotherapy).
•Previous history with positive Her-2 expression requires anti-Her-2 medication; unknown Her-2 expression should define Her-2 status before enrollment.
•Adequate main organ function.
•Eastern Cooperative Oncology Group (ECOG) score 0-
•Expected lifetime≥ 3 months.
•Female patients of childbearing age must have a negative serum pregnancy test within 7 days prior to randomization; patients must agree to take adequate contraception from signing of ICF through 6 months after last dose, during which time women are not breastfeeding; male patients must agree to contraception and refuse sperm donation.
•At least one assessable lesion according to RECIST V1.1; The area should not have received radiotherapy in the past, or there is evidence that the lesion has made definite progress after radiotherapy.

Exclusion Criteria

•Other active malignant tumors in the first 5 years of randomization.
•Uncontrolled serous cavity effusion requiring frequent drainage or medical intervention within 7 days before randomization.
•Patients with central nervous system metastasis.
•Patients whose previous medical history shows dMMR/MSI-H and who have not received immunotherapy in the past are not suitable for enrollment, and those whose dMMR/MSI status is unknown need to clarify the status before enrolment.
•Patients who have used paclitaxel/docetaxel in the past (except patients with disease progression more than one year after neoadjuvant/adjuvant treatment with paclitaxel/docetaxel).
•History of serious cardiovascular disease within 6 months before randomization.
•History of gastrointestinal perforation and/or fistula within 6 months before randomization.
•Hypertension with poor control during the screening period.
•Patients with active hepatitis B, hepatitis C or HIV.
•Patients with severe chronic or active infections that require systemic antimicrobial, antifungal, or antiviral therapy.