A Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer

NCT05705635 | Unknown Phase 2

• 1 other identifier: HB1801-007
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Adenocarcinoma; Adenocarcinoma of Gastroesophageal Junction

Keywords

gastric adenocarcinoma, gastroesophageal junction adenocarcinoma,Docetaxel,Albumin-bound

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival (PFS)

  The duration is from the randomized time to disease progression or death due to any reason.

  Up to approximately 2 years

Secondary Outcomes (5)

• Overall response rate (ORR)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of Response (DoR)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

• Incidence of AE and SAE

  Up to approximately 2 years

Other Outcomes (1)

• Plasma concentration of docetaxel (free and total)

  At the end of Cycle 1（each cycle is 21 days）

Study Arms (2)

Docetaxel for Injection (Albumin-bound)

EXPERIMENTAL

Docetaxel for Injection (Albumin-bound) will be administrated by intravenous infusion once every 3 weeks.

Drug: Docetaxel for injection (Albumin-bound)

Taxotere

ACTIVE COMPARATOR

Taxotere will be administrated by intravenous infusion once every 3 weeks.

Drug: Taxotere

Interventions

Docetaxel for injection (Albumin-bound) DRUG

Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks.

Docetaxel for Injection (Albumin-bound)

Taxotere DRUG

Taxotere, by intravenous infusion, every 3 weeks.

Taxotere

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 0-1.
• 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.

You may not qualify if:

• 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.
• Patients with gastrointestinal obstruction and active inflammatory bowel disease within 28 days before randomization.
• Toxic reaction caused by any previous treatment has not recovered to level 1 or below (CTCAE5.0).
• Major organ surgery (except puncture biopsy) within 28 days before randomization.
• Have received chemotherapy, radiotherapy, targeted therapy, immunotherapy or other anti-tumor treatment of clinical research drugs within 28 days before randomization.
• Have received traditional Chinese medicine with anti-tumor indications within 14 days before randomization.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Ethics Committee of Sun-Yat-Sen University Cancer Center

Guangzhou, China

RECRUITING

MeSH Terms

Interventions

Docetaxel; Injections

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ruihua Xu

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Ruihua Xu

CONTACT

+86-20-87343468; xurh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: January 31, 2023
• Study Start: January 13, 2023
• Primary Completion: May 1, 2023
• Study Completion: December 1, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)