Clinical trial · Interventional
Effect of HIPEC After Radical Surgery on Long-term Survival for Locally Advanced Gastric Cancer
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
NCT06525714CI-TRIAL-00079301not yet recruitingEarly Phase 1ClinicalTrials.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)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Survival Rate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin oxaliplatin tegafur | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cisplatin, oxaliplatin, tegafur.
- description
- Cisplatin, oxaliplatin, tegafur.
- interventionNames
- Drug: cisplatin oxaliplatin tegafur
Primary outcomes (1)
- measure
- 3-year overall survival rate
- timeFrame
- Three years after treatment
- description
- Three-year overall survival after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>18 and ≤70 years; 2. Male or nonpregnant female; 3. Gastric adenocarcinoma cT3N+M0 and cT4aN+/-M0 (according to the 8th edition of the AJCC TNM staging system); 4. No distant metastasis, suitable for D2 lymph node dissection; 5. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2; 6. No prior cytotoxic chemotherapy, radiotherapy, or immunotherapy; 7. Written informed consent given before any study-related procedures; Exclusion Criteria: 1. Other cancers within the past 5 years; 2. Distant metastasis (M1) found during surgery; 3. ASA (American Society of Anesthesiologists) classification ≥IV and/or ECOG performance status \>2; 4. Severe liver, kidney, cardiac, pulmonary, or coagulation dysfunction, or severe underlying diseases that make the patient unable to tolerate surgery; 5. A history of severe mental illness; 6. History of taking steroid medications; 7. Receiving other chemotherapy, radiotherapy, or immunotherapy; 8. Lack of written informed consent;
References
Publications (13)
- BACKGROUNDSung 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
- BACKGROUNDFeng 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
- BACKGROUNDSaito 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
- BACKGROUNDSong 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
- BACKGROUNDJo 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
- BACKGROUNDTustumi 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
- BACKGROUNDSticca 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.