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Not yet recruiting NCT06525714

Effect of HIPEC After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer

Early Phase I Interventional Gastric Cancer Survival Rate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cisplatin oxaliplatin tegafur.
Who it may be relevant to
Registry conditions: Gastric Cancer, Survival Rate. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Prophylactic Hyperthermic Intraperitonal Chemotherapy（HIPEC）After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer（cT3N+M0 and cT4aN+/-M0）: A Randomized-controlled Study

Overview

The study focuses on patients with locally advanced gastric adenocarcinoma (cT3N+M0 and cT4aN+/-M0), assessing the feasibility, surgical safety, and oncological benefit of prophylactic HIPEC treatment following laparoscopic D2 radical surgery.

Detailed description

Patients meeting the inclusion criteria will undergo laparoscopic D2 radical surgery. Before closing the abdomen during surgery, heat perfusion tubes are inserted, typically placing four tubes in a cross arrangement. Two drainage tubes at the pelvic floor exit through the upper abdomen, and two drainage tubes at the hepatorenal and splenorenal recesses exit through the lower abdomen, thus completing the tube placement.

Within 48 hours postoperative, the first infusion was performed with 3000-4000 ml of saline and 50 mg/m2 cisplatin at 43°C, with an infusion rate of 600 ml/min for a duration of 2 hours. During treatment, close attention is given to the patient's heart rate, blood pressure, oxygenation, and other vital signs. A total of 2 HIPEC treatments were conducted, each 48 hours apart. Systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using SOX: intravenous injection of oxaliplatin (130 mg/m2) on the first day and oral administration of tegafur (40-60 mg twice daily, with doses adjusted for body surface area: \<1.25 m2, 40 mg; 1.25m2 ≤ body surface area ≤ 1.5m2, 50mg; body surface area \>1.5m2, 60 mg bid) from day 1 to 14.

HIPEC is not performed postoperative. Systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using SOX: intravenous injection of oxaliplatin (130 mg/m2) on the first day and oral administration of tegafur (40-60 mg twice daily, with doses adjusted for body surface area: \<1.25 m2, 40 mg; 1.25m2 ≤ body surface area ≤ 1.5m2, 50mg; body surface area \>1.5m2, 60 mg bid) from day 1 to 14.

Interventions

  • Drug cisplatin oxaliplatin tegafur
    Within 48 hours postoperative, the first infusion was performed with 3000-4000 ml of saline and 50 mg/m2 cisplatin at 43°C, with an infusion rate of 600 ml/min for a duration of 2 hours. During treatment, close attention is given to the patient's heart rate, blood pressure, oxygenation, and other vital signs. A total of 2 HIPEC treatments were conducted, each 48 hours apart. Systemic chemotherapy is initiated 3-4 weeks postoperative for 6-8 cycles using SOX: intravenous injection of oxaliplatin

Primary outcome measures

  • 3-year overall survival rate [Time frame: Three years after treatment]

Eligibility criteria

Inclusion criteria

  • Age >18 and ≤70 years;
  • Male or nonpregnant female;
  • Gastric adenocarcinoma cT3N+M0 and cT4aN+/-M0 (according to the 8th edition of the AJCC TNM staging system);
  • No distant metastasis, suitable for D2 lymph node dissection;
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0-2;
  • No prior cytotoxic chemotherapy, radiotherapy, or immunotherapy;
  • Written informed consent given before any study-related procedures;

Exclusion criteria

  • Other cancers within the past 5 years;
  • Distant metastasis (M1) found during surgery;
  • ASA (American Society of Anesthesiologists) classification ≥IV and/or ECOG performance status >2;
  • Severe liver, kidney, cardiac, pulmonary, or coagulation dysfunction, or severe underlying diseases that make the patient unable to tolerate surgery;
  • A history of severe mental illness;
  • History of taking steroid medications;
  • Receiving other chemotherapy, radiotherapy, or immunotherapy;
  • Lack of written informed consent;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
  • Feng RM, Zong YN, Cao SM, Xu RH. Current cancer situation in China: good or bad news from the 2018 Global Cancer Statistics? Cancer Commun (Lond). 2019 Apr 29;39(1):22. doi: 10.1186/s40880-019-0368-6. PMID 31030667
  • Saito H, Kono Y, Murakami Y, Kuroda H, Matsunaga T, Fukumoto Y, Tomohiro O, Fujiwara Y. Gross Appearance and Curability Are Predictive Factors of a Better Prognosis After Gastrectomy in Gastric Cancer Patients with Metastasis to the Adjacent Peritoneum of the Stomach. Yonago Acta Med. 2017 Sep 15;60(3):174-178. eCollection 2017 Sep. PMID 28959128
  • Song H, Wang T, Tian L, Bai S, Chen L, Zuo Y, Xue Y. Macrophages on the Peritoneum are involved in Gastric Cancer Peritoneal Metastasis. J Cancer. 2019 Aug 29;10(22):5377-5387. doi: 10.7150/jca.31787. eCollection 2019. PMID 31632482
  • Jo JC, Ryu MH, Koo DH, Ryoo BY, Kim HJ, Kim TW, Choi KD, Lee GH, Jung HY, Yook JH, Oh ST, Kim BS, Kim JH, Kang YK. Serum CA 19-9 as a prognostic factor in patients with metastatic gastric cancer. Asia Pac J Clin Oncol. 2013 Dec;9(4):324-30. doi: 10.1111/ajco.12019. Epub 2012 Nov 26. PMID 23176400
  • Tustumi F, Bernardo WM, Dias AR, Ramos MF, Cecconello I, Zilberstein B, Ribeiro-Junior U. Detection value of free cancer cells in peritoneal washing in gastric cancer: a systematic review and meta-analysis. Clinics (Sao Paulo). 2016 Dec 1;71(12):733-745. doi: 10.6061/clinics/2016(12)10. PMID 28076519
  • Sticca RP, Dach BW. Rationale for hyperthermia with intraoperative intraperitoneal chemotherapy agents. Surg Oncol Clin N Am. 2003 Jul;12(3):689-701. doi: 10.1016/s1055-3207(03)00029-2. PMID 14567025
  • Rau B, Brandl A, Thuss-Patience P, Bergner F, Raue W, Arnold A, Horst D, Pratschke J, Biebl M. The efficacy of treatment options for patients with gastric cancer and peritoneal metastasis. Gastric Cancer. 2019 Nov;22(6):1226-1237. doi: 10.1007/s10120-019-00969-1. Epub 2019 May 7. PMID 31065877

Identifiers

NCT: NCT06525714 · W100110120

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗