Clinical trial NCT05667415: Treatment of Advance Gastric Cancer With Disulfiram
Official title: Clinical Study of Disulfiram Combined With Cisplatin in the Treatment of Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chemotherapy；Advanced Gastric Cancer；Cisplatin；Disulfiram
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
Collaborators: name: College of Pharmaceutical Sciences at Zhejiang University
name: The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University
First posted: 2022-12-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Combination regimen of disulfiram and cisplatin for gastric cancer and standard cisplatin regimen for gastric cancer
Primary purpose: TREATMENT

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.

Eligibility criteria: 1. Inclusion criteria: ① Age ≥18 years old; ② Gastric cancer is confirmed through gastroscopy biopsy; ③ The patient meets the relevant diagnostic criteria in People's Republic of China (PRC) Health Industry Standards: Diagnostic Criteria for Gastric Cancer, and has reached the level of stage III and IV futures, and the patient refuses to receive surgical treatment; ④ Estimated survival time \> 3 months; ⑤ Without any chemotherapy treatment or more than one month from the end of the last chemotherapy course; ⑥Karnofsky functional status score ≥ 60;
2. Exclusion criteria: ① patients who had allergic reaction to therapeutic drugs; ② patients with other types of cancer; ③ Patients with severe diseases of heart, liver, kidney, etc.; (4) gastrointestinal dysfunction or unable to oral medication.
3. Shedding/eliminating criteria: exiting in the midway; Lost to follow-up during the follow-up period; Treatment was not continued according to the treatment protocol.

Primary outcomes:
measure: Complete response (CR)
timeFrame: every 6 weeks
measure: Partial response (PR)
timeFrame: every 6 weeks
measure: Stable disease (SD)
timeFrame: every 6 weeks
measure: Disease progression (PD)
timeFrame: every 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou first people's Hospital
state: Zhejiang
Study officials:
References: