Comparing Lobaplatin and Paclitaxel for Advanced Gastric Cancer Treatment
Comparative Study on the Efficacy of Lobaplatin and Paclitaxel in the Treatment of Advanced Gastric Cancer Patients With D2 Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy
This study is testing whether Lobaplatin or Paclitaxel works better for people with advanced gastric cancer who are having surgery and special heated chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 231 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Wuhan Union Hospital, China Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT04808466 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of Lobaplatin and Paclitaxel in patients with advanced gastric cancer who undergo D2 surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC). It is a prospective, randomized study involving 231 participants, who will be divided into three groups: two receiving different chemotherapy drugs and one control group. The study will evaluate outcomes such as peritoneal metastasis, overall survival, immune status, and safety during the perioperative period. The goal is to determine the optimal chemotherapy regimen to enhance treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a pathological diagnosis of gastric adenocarcinoma at T3 stage or above, without distant metastasis.
Not a fit: Patients with a history of other malignant tumors, distant metastasis at surgery, or allergies to the study drugs may not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and treatment outcomes for patients with advanced gastric cancer.
How similar studies have performed: Previous studies have shown promising results with HIPEC in advanced gastric cancer, but the specific comparison of Lobaplatin and Paclitaxel is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. No chemoradiotherapy or other anti-tumor therapy before clinical trial performed; 2. Aged 18-75 years; 3. Male or non-pregnant or lactating women; 4. Pathological diagnosis of gastric adenocarcinoma; 5. Clinical diagnosis of T3 stage or above without distant metastasis and can be given D2 radical resection (AJCC Version 8, 2018); 6. Normal function of major organs; 7. Routine blood examinations meeting the following criteria: A. HB ≥ 90 g/L; B. ANC ≥ 1.5 x 10 9 /L; C. PLT ≥ 125 × 10 9 /L; 8. Chemistry indexs meeting the following criteria: A. TBIL \< 1.5ULN; B. ALT and AST \< 2.5ULN; ALB \> 30 g/L C. serum Cr ≤ 1.25 ULN or endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula); 9. ECOG score 0-1; Exclusion Criteria: 1. A history of other malignant tumors within 5 years; 2. Distant metastasis found during surgery; 3. Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs; 4. Suffering from epilepsy or other mental illness, unable to control behavior; 5. Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease; 6. Pregnant or lactating women. 7. Receiving anti-cancer drug therapy from other clinical trials.
Where this trial is running
Wuhan, Hubei
- Wuhan Union Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Kaixiong Tao, Professor — Wuhan Union Hospital, China
- Study coordinator: Kaixiong Tao, Professor
- Email: kaixiongtao@hust.edu.cn
- Phone: +86- 027-85351662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.