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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Adenocarcinoma; Adenocarcinoma of Gastroesophageal Junction
• Intervention / Treatment: Drug: Docetaxel for injection (Albumin-bound); Drug: Taxotere

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ruihua Xu; Phone Number: +86-20-87343468; Email: xurh@sysucc.org.cn

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Ethics Committee of Sun-Yat-Sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age: 18-75 (inclusive) (Whichever is on the day of signing the informed consent form).
2. Willing to sign the informed consent form, willing and able to follow the program to accept visits, treatment and laboratory tests.
3. Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by histology or cytology.
4. 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).
5. Previous history with positive Her-2 expression requires anti-Her-2 medication; unknown Her-2 expression should define Her-2 status before enrollment.
6. Adequate main organ function.
7. Eastern Cooperative Oncology Group (ECOG) score 0-1.
8. Expected lifetime≥ 3 months.
9. 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.
10. 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:

1. Other active malignant tumors in the first 5 years of randomization.
2. Uncontrolled serous cavity effusion requiring frequent drainage or medical intervention within 7 days before randomization.
3. Patients with central nervous system metastasis.
4. 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.
5. 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).
6. History of serious cardiovascular disease within 6 months before randomization.
7. History of gastrointestinal perforation and/or fistula within 6 months before randomization.
8. Hypertension with poor control during the screening period.
9. Patients with active hepatitis B, hepatitis C or HIV.
10. Patients with severe chronic or active infections that require systemic antimicrobial, antifungal, or antiviral therapy.
11. Patients with gastrointestinal obstruction and active inflammatory bowel disease within 28 days before randomization.
12. Toxic reaction caused by any previous treatment has not recovered to level 1 or below (CTCAE5.0).
13. Major organ surgery (except puncture biopsy) within 28 days before randomization.
14. Have received chemotherapy, radiotherapy, targeted therapy, immunotherapy or other anti-tumor treatment of clinical research drugs within 28 days before randomization.
15. Have received traditional Chinese medicine with anti-tumor indications within 14 days before randomization.
16. Have received powerful CYP3A4 inhibitor or inducer within 14 days before randomization.
17. Allergic to and / or contraindication to albumin or docetaxel.
18. Known allergy and/or contraindication to glucocorticoids.
19. Patients with psychiatric neurological disorders that may affect trial adherence, or patients with a history of drug dependence / alcohol dependence.
20. Other situations that the researcher thinks are not suitable for participating in this study.
21. Patients participated in another clinical study at the same time, unless it is an observational (non intervention) clinical study or is in the follow-up period of an intervention study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Docetaxel for Injection (Albumin-bound); Docetaxel for Injection (Albumin-bound) will be administrated by intravenous infusion once every 3 weeks.	Drug: Docetaxel for injection (Albumin-bound); Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks.
ACTIVE_COMPARATOR: Taxotere; Taxotere will be administrated by intravenous infusion once every 3 weeks.	Drug: Taxotere; Taxotere, by intravenous infusion, every 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AE and SAE		Up to approximately 2 years
Overall response rate (ORR)	The primary endpoint is objective response rate,which equals CR+PR.	Up to approximately 2 years
Disease control rate (DCR)	The primary endpoint is Disease Control rate,which equals CR+PR+SD.	Up to approximately 2 years
Duration of Response (DoR)	The time from the first assessment of tumor as CR or PR to the first assessment as PD or death from any cause	Up to approximately 2 years
Overall survival (OS)	OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 12 weeks till death or lost	Up to approximately 2 years

Other Outcome Measures

Outcome Measure	Time Frame
Plasma concentration of docetaxel (free and total)	At the end of Cycle 1（each cycle is 21 days）

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Investigators: Study Chair: Ruihua Xu, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2023
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (ACTUAL): January 31, 2023

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: gastric adenocarcinoma, gastroesophageal junction adenocarcinoma,Docetaxel,Albumin-bound
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: HB1801-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No