Clinical trial NCT03822130: Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate for Unresectable Gastric Cancer
Official title: A Randomized Controlled Trial for Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate and Systemic Chemotherapy for Unresectable Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Successful Conversion Rate of Operation
Unresectable Gastric Cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 150
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 project intends to compare the clinical effects and side effects of three kinds of treatment methods in the treatment of unresectable gastric cancer by intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate and systemic chemotherapy. It is clear that intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate is not suitable for the treatment of unresectable gastric cancer. The clinical practice value of resection of gastric cancer can provide high quality evidence-based medical basis for the treatment guidelines of advanced gastric cancer, and explore a new clinical technology with exact curative effect and higher safety.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 to 75 years;
2. Ultrasound gastroscopy or imaging (CT) can diagnose potentially unresectable gastric cancer (T4a-bN2-3M0) with indications of neoadjuvant chemotherapy or transformation therapy;
3. Pathological diagnosis of gastric cancer;
4. No contraindication of chemotherapy;
5. Patients who did not undergo chemotherapy or were diagnosed for the first time.

Exclusion Criteria:

1. Those who fail to comply with the requirements of the trial, obviously violate this regimen, or change to other regimens in the course of treatment;
2. The life expectancy of patients with extensive systemic metastasis is less than 3 months;
3. Leukocyte count is less than 2\*109/L and platelet count is less than 75\*10\^9/L;
4. Severe heart, liver and kidney diseases, unable to tolerate chemotherapy;
5. Patients without gastric cancer complications such as massive gastrointestinal bleeding and perforation need to be treated in emergency department;
6. Patients with distant metastasis (excluding group 16 lymph node metastasis);
7. Patients with other tumors, with a history of malignant tumors (excluding early primary cancers);
8. The patient himself asked to withdraw from the trial;
9. Researchers believe that patients are not suitable for this study.

Primary outcomes:
measure: Successful conversion rate of operation
timeFrame: 42 days
Secondary outcomes:
measure: ORR
timeFrame: 42 days
measure: PFS
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: