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

ConditionGastric Cancer

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age: 18-75 years (inclusive) (Whichever is on the day of signing the informed consent form).

2. Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by histology or cytology.

3. 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).

4. Evidence of disease progression on imaging during or after the last systemic treatment as confirmed by investigator.

Disqualifiers

1. 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).

2. 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).

3. Patients with central nervous system metastasis.

4. 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).

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

630 Participants

are divided into 2 treatment groups

Group A: Docetaxel for Injection (Albumin-bound)Experimental treatment 1 intervention

Group B: Taxotere (Docetaxel)Active comparator 1 intervention