Actively Recruiting
Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma
Led by Peking University Cancer Hospital & Institute · Updated on 2023-04-05
95
Participants Needed
1
Research Sites
372 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 conversion therapy for initial unresectable local progression or potential resectable metastatic gastric adenocarcinoma.
CONDITIONS
Official Title
Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Karnofsky Performance Status Score of 70 or higher
- Histological diagnosis of HER2-negative gastric adenocarcinoma
- Initial unresectable locally advanced or potentially resectable metastatic gastric adenocarcinoma, including single liver metastases, localized abdominal para-aortic lymph node metastasis, or positive abdominal free cancer cells
- Physical condition and organ function suitable for major abdominal surgery
- Baseline blood routine and biochemistry meeting specific thresholds for hemoglobin, neutrophils, platelets, liver enzymes, bilirubin, creatinine, and serum albumin
- Echocardiographic left ventricular ejection fraction of 50% or higher
- No serious accompanying diseases limiting survival to less than 5 years
- Ability and agreement to follow study protocol
- Provided written informed consent prior to screening
You will not qualify if you...
- Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for gastric cancer, except corticosteroids
- Pregnant or breastfeeding women
- Women of childbearing age with positive pregnancy test or no pregnancy test; menopausal for less than 12 months
- Men and women unwilling to use contraception during the study if fertility is possible
- Patients with ascites and positive abdominal free cancer cells
- History of other malignant diseases in the last 5 years except cured skin cancer or cervical carcinoma in situ
- History of epilepsy, central nervous system disease, or mental disorder that may affect informed consent or medication compliance
- Severe active heart disease or recent myocardial infarction within 12 months
- Upper gastrointestinal issues affecting S-1 absorption
- Known peripheral neuropathy grade 2 or higher except absent deep tendon reflex without symptoms
- Organ transplant patients requiring immunosuppressive therapy
- Severe uncontrolled infections or other serious uncontrolled diseases
- Moderate or severe renal impairment with creatinine clearance ≤50 ml/min or elevated serum creatinine
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Allergy to taxanes or study medications
- Participation in other clinical trials within 4 weeks prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
J
Jiafu ji, MD
CONTACT
Z
Zhaode Bu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here