Clinical trial · Interventional
Comparative Study of Lobaplatin and Paclitaxel in Advanced Gastric Cancer Patients With D2 Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy
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
NCT04808466CI-TRIAL-00056645WUHIPEC01unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective, randomized, comparative clinical trial conducted by Wuhan Union Hospital and aim to compare the therapeutic effects of Lobaplatin and Paclitaxel in advanced gastric cancer patients with D2 surgery combined with hyperthermic intraperitoneal chemotherapy
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Metastasis | Gastric Neoplasm | PROBABILISTIC | 0.70 |
| Surgery | — | UNRESOLVED | — |
| Survival | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lobaplatin | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Drug group 1
- description
- hyperthermic intraperitoneal chemotherapy (HIPEC) (with paclitaxel): Temperature Setting : 43 ± 1.0 ℃. Perfusion time: 60 min. Amount of perfusate: The perfusion fluid is based on the principle of filling the abdominal cavity and unobstructed circulation. Choice of perfusate: Normal saline. Drug selection and dose: Paclitaxel 75 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).
- interventionNames
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- Drug group 2
- description
- hyperthermic intraperitoneal chemotherapy (HIPEC) (with lobaplatin): Temperature Setting : 43 ± 1.0 ℃. Perfusion time: 60 min. Amount of perfusate: The perfusion fluid is based on the principle of filling the abdominal cavity and unobstructed circulation. Choice of perfusate: Normal saline. Drug selection and dose: lobaplatin 50 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).
- interventionNames
- Drug: Lobaplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDMacdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30. doi: 10.1056/NEJMoa010187. PMID 11547741
- RESULTYonemura Y, de Aretxabala X, Fujimura T, Fushida S, Katayama K, Bandou E, Sugiyama K, Kawamura T, Kinoshita K, Endou Y, Sasaki T. Intraoperative chemohyperthermic peritoneal perfusion as an adjuvant to gastric cancer: final results of a randomized controlled study. Hepatogastroenterology. 2001 Nov-Dec;48(42):1776-82. PMID 11813623
- RESULTFujimoto S, Takahashi M, Mutou T, Kobayashi K, Toyosawa T. Successful intraperitoneal hyperthermic chemoperfusion for the prevention of postoperative peritoneal recurrence in patients with advanced gastric carcinoma. Cancer. 1999 Feb 1;85(3):529-34. PMID 10091726
- RESULTTorphy RJ, Stewart C, Sharma P, Halpern AL, Oase K, Herter W, Bartsch C, Friedman C, Del Chiaro M, Schulick RD, Gleisner A, McCarter MD, Ahrendt SA. Dextrose-Containing Carrier Solution for Hyperthermic Intraperitoneal Chemotherapy: Increased Intraoperative Hyperglycemia and Postoperative Complications. Ann Surg Oncol. 2020 Dec;27(13):4874-4882. doi: 10.1245/s10434-020-08330-y. Epub 2020 Apr 19. PMID 32306237
- RESULTHamazoe R, Maeta M, Kaibara N. Intraperitoneal thermochemotherapy for prevention of peritoneal recurrence of gastric cancer. Final results of a randomized controlled study. Cancer. 1994 Apr 15;73(8):2048-52. doi: 10.1002/1097-0142(19940415)73:83.0.co;2-q. PMID 8156509