Treatment of Advance Gastric Cancer With Disulfiram
- Conditions
- Chemotherapy；Advanced Gastric Cancer；Cisplatin；Disulfiram
- Interventions
- Registration Number
- NCT05667415
- Lead Sponsor
- First People's Hospital of Hangzhou
- Brief Summary
Chemotherapy is generally needed for advanced gastric cancer, and cisplatin is the main chemotherapy drug. However, there are many adverse reactions, including bone marrow suppression, gastrointestinal reactions, renal toxicity and neurotoxicity. These adverse reactions can affect the comfort and compliance of patients during treatment. At present, it is necessary to reduce adverse reactions of cisplatin and increase the chemotherapy sensitivity of gastric cancer to cisplatin. Recent studies have found that disulfiram has a potential anti-tumor effect. The disulfiram has shown significant in vivo and in vitro anti-tumor activity in preclinical studies, and has become a potential candidate drug for tumor treatment as an adjuvant in various clinical trials. In this clinical study, cisplatin combined with disulfiram is mainly used to treat advanced gastric cancer.
- Detailed Description
Chemotherapy is generally needed for advanced gastric cancer, and cisplatin is the main chemotherapy drug. However, there are many adverse reactions, including bone marrow suppression, gastrointestinal reactions, renal toxicity and neurotoxicity. These adverse reactions can affect the comfort and compliance of patients during treatment. At present, it is necessary to reduce adverse reactions of cisplatin and increase the chemotherapy sensitivity of gastric cancer to cisplatin. Recent studies have found that disulfiram has a potential anti-tumor effect. The disulfiram has shown significant in vivo and in vitro anti-tumor activity in preclinical studies, and has become a potential candidate drug for tumor treatment as an adjuvant in various clinical trials. In this clinical study, cisplatin combined with disulfiram is mainly used to treat advanced gastric cancer.Subjects were randomized in a 1:1 ratio, one group being the control group and the other group being the observation group. Control group: On the first day of treatment, the patients were given intravenous drip of 80mg/m2 cisplatin, 21 days as a course of treatment, lasting for six courses. Observation group: On the first day of treatment, the patients were given intravenous drip of 80mg/m2 cisplatin, 21 days as a course of treatment, lasting for six courses. Disulfiram 400mg was given orally daily and continued until the end of the chemotherapy course. Based on the patient's tolerance to disulfiram, the disulfiram dose may be reassessed during treatment with a minimum oral dose of 125mg per day. The clinical symptoms, signs and adverse reactions were observed in the patients, and the treatment effect was evaluated after three weeks as a cycle and two cycles.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description disulfiram and cisplatin disulfiram and cisplatin Cisplatin combined with disulfiram chemotherapy standard cisplatin cisplatin Cisplatin chemotherapy alone
- Primary Outcome Measures
Name Time Method Stable disease (SD) every 6 weeks the overall reduction or increase of the longest diameter of the tumor lesion is \< 50% or \< 25%, and the duration is \> 4 weeks; no new lesion appears
Disease progression (PD) every 6 weeks the combined increase in the longest diameter of the tumor lesion is ≥25%, or a new lesion appears
Complete response (CR) every 6 weeks The tumor lesion in our patient completely resolved and lasted for ≥4 weeks, and no new lesion appeared
Partial response (PR) every 6 weeks the overall reduction in the longest diameter of the tumor focus is \> 50% and it can be maintained for at least 4 weeks, with no new focus emerging
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hangzhou first people's Hospital
🇨🇳Hangzhou, Zhejiang, China