Clinical trial NCT05705635: A Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Adenocarcinoma
Adenocarcinoma of Gastroesophageal Junction
Keywords: gastric adenocarcinoma, gastroesophageal junction adenocarcinoma,Docetaxel,Albumin-bound
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free-Survival (PFS)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: Up to approximately 2 years
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
measure: Duration of Response (DoR)
timeFrame: Up to approximately 2 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
measure: Incidence of AE and SAE
timeFrame: Up to approximately 2 years
Other outcomes:
measure: Plasma concentration of docetaxel (free and total)
timeFrame: At the end of Cycle 1（each cycle is 21 days）
Locations:
city: Guangzhou
country: China
facility: Ethics Committee of Sun-Yat-Sen University Cancer Center
Study officials:
affiliation: Sun Yat-sen University
name: Ruihua Xu
role: STUDY_CHAIR
References: