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

NCT06296706 | Recruiting Phase 3

• 1 other identifier: HB1801-010
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a multicenter, randomized, controlled phase Ш clinical study of comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with previous first-line treatment failure.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• OS

  Overall survival (OS)

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

Secondary Outcomes (6)

• ORR

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

• PFS

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

• DCR

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

• DoR

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

• The incidence and severity of adverse events (AE) and severe adverse events (SAE)

  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 (Docetaxel)

ACTIVE COMPARATOR

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

Drug: Taxotere (docetaxel)

Interventions

Docetaxel for injection (Albumin-bound) DRUG

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

Also known as: HB1801

Docetaxel for Injection (Albumin-bound)

Taxotere (docetaxel) DRUG

Taxotere, by intravenous infusion, every 3 weeks.

Also known as: Taxotere

Taxotere (Docetaxel)

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 years (inclusive) (Whichever is on the day of signing the informed consent form).
• \. Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by histology or cytology.
• \. Locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction that has progressed after receiving first-line systematic treatment (defined as platinum/fluorouracil containing dual drug chemotherapy, with or without immunotherapy).
• \. Evidence of disease progression on imaging during or after the last systemic treatment as confirmed by investigator.
• \. At least one assessable lesion according to RECIST V1.1; the area should not have received previous radiotherapy, or there should be evidence of definite progress of the lesion after completion of radiotherapy.
• \. 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.
• \. Fully understand this clinical trial and willing to sign a written informed consent form.

You may not qualify if:

• \. Medical history of other malignant tumors or other active malignant tumors within 5 years prior to randomization (cured local tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included).
• \. Uncontrolled serous cavity effusion requiring frequent drainage or medical intervention within 14 days before randomization (Additional intervention is required within 2 weeks after intervention, such as pleural effusion, abdominal effusion, pericardial effusion, etc., excluding exfoliative cytology testing of exudate).
• \. Patients with central nervous system metastasis.
• \. 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).
• \. Patients whose previous medical history shows dMMR/MSI-H (deficient Mismatch Repair or High Microsatellite Instability) 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 enrollment.
• \. History of serious cardiovascular or cerebrovascular disease, including but not limited to:
• Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, etc;
• Acute coronary syndrome, congestive heart failure, stroke, or other level 3 or higher cardiovascular events occurring within 6 months before randomization;
• The New York Heart Association (NYHA) heart function rating of ≥ Grade Ⅱ or left ventricular ejection fraction (LVEF) of\<50%;
• Long QTc syndrome or QTc interval\>480 milliseconds, as well as the use of any known concomitant medication that can prolong the QT interval;
• Poor control of hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg during the screening period).
• \. History of gastrointestinal perforation and/or fistula within 6 months before randomization.
• \. Patients with active hepatitis B(Hepatitis B surface antigen (HBsAg) or HBcAb -positive, and in the active phase of hepatitis B (HBV-DNA ≥ 10\^4 cps/mL or ≥ 2000 IU/mL)), hepatitis C(Hepatitis C antibody (Anti HCV) positive and tested positive for HCV RNA by PCR) or HIV.
• \. Patients with severe chronic or active infections that require systemic antimicrobial, antifungal, or antiviral therapy within 14 days before randomization. Note: Patients with viral hepatitis are allowed to receive antiviral treatment.
• \. Tuberculosis treatment history within 2 years before randomization.

Sponsors & Collaborators

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

Study Sites (1)

CSPC Zhongqi Technology(SJZ) Ltd

Shijiazhuang, Hebei, 050035, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Injections

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

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, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-31169085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: February 27, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

CN (1)