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

NCT06525714 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: W100110120
• Study Type: interventional
• Target: 302
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastric Cancer; Survival Rate

Outcome Measures

Primary Outcomes (1)

• 3-year overall survival rate

  Three-year overall survival after treatment

  Three years after treatment

Study Arms (1)

Cisplatin, oxaliplatin, tegafur.

EXPERIMENTAL

Cisplatin, oxaliplatin, tegafur.

Drug: cisplatin oxaliplatin tegafur

Interventions

cisplatin oxaliplatin tegafur DRUG

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.

Cisplatin, oxaliplatin, tegafur.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Related Publications (13)

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MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized-controlled study

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 29, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share