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Gastric CancerEarly Phase 1NCT06525714

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

A Early Phase 1 study testing cisplatin oxaliplatin tegafur in people with Gastric Cancer and Survival Rate, run by The First Hospital of Jilin University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Gastric Cancer, Survival Rate
What is being tested?
cisplatin oxaliplatin tegafur
Could I receive a placebo?
No, everyone receives an active treatment
How many people
302 participants
Where
No sites listed yet
Study dates
Aug 2024to Jul 2030
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;

About this study

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

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.

Read the 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.

Being tested
cisplatin oxaliplatin tegafur
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatin oxaliplatin tegafurDrug

    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.

Study groups in NCT06525714
Study groupRoleWhat they receive
Cisplatin, oxaliplatin, tegafur.ExperimentalCisplatin, oxaliplatin, tegafur.
Receives: Drug: cisplatin oxaliplatin tegafur

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year overall survival rate

    Three-year overall survival after treatment

    Measured: Three years after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study startAug 2024 (estimated)
  3. Primary completionJul 2029 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A randomized-controlled study
Masking
None (open label)
Enrolment
302 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06525714
Sponsor's protocol ID
W100110120
Status last verified
Jul 2024
First submitted
25 Jul 2024
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There are plans to make individual participant data (IPD) available to other researchers. Includes only basic information such as name and gender.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 31065877
  • Yu HH, Yonemura Y, Ng HJ, Lee MC, Su BC, Hsieh MC. Benefit of Neoadjuvant Laparoscopic Hyperthermic Intraperitoneal Chemotherapy and Bidirectional Chemotherapy for Patients with Gastric Cancer with Peritoneal Carcinomatosis Considering Cytoreductive Surgery. Cancers (Basel). 2023 Jun 29;15(13):3401. doi: 10.3390/cancers15133401.

    PubMed 37444511
  • Hung HC, Hsu PJ, Lee CW, Hsu JT, Wu TJ. Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy for Gastric Cancer with Peritoneal Carcinomatosis: Additional Information Helps to Optimize Patient Selection before Surgery. Cancers (Basel). 2023 Mar 31;15(7):2089. doi: 10.3390/cancers15072089.

    PubMed 37046754
  • Zhong Y, Kang W, Hu H, Li W, Zhang J, Tian Y. Lobaplatin-based prophylactic hyperthermic intraperitoneal chemotherapy for T4 gastric cancer patients: A retrospective clinical study. Front Oncol. 2023 Jan 18;13:995618. doi: 10.3389/fonc.2023.995618. eCollection 2023.

    PubMed 36741012
  • Zhang J, Sun Y, Bai X, Wang P, Tian L, Tian Y, Zhong Y. Single versus multiple hyperthermic intraperitoneal chemotherapy applications for T4 gastric cancer patients: Efficacy and safety profiles. Front Oncol. 2023 Mar 17;13:1109633. doi: 10.3389/fonc.2023.1109633. eCollection 2023.

    PubMed 37007142
  • Bazarbashi S, Badran A, Gad AM, Aljubran A, Alzahrani A, Alshibani A, Alrakaf R, Elhassan T, Alsuhaibani A, Elshenawy MA. Combined Prophylactic Hyperthermic Intraperitoneal Chemotherapy and Intraoperative Radiotherapy for Localized Gastroesophageal Junction and Gastric Cancer: A Comparative Nonrandomized Study. Ann Surg Oncol. 2023 Jan;30(1):426-432. doi: 10.1245/s10434-022-12467-3. Epub 2022 Aug 30.

    PubMed 36042103

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing cisplatin oxaliplatin tegafur in people with Gastric Cancer and Survival Rate, run by The First Hospital of Jilin University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year overall survival rate (time frame: Three years after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06525714, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.

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