PHASE II EVALUATION OF CYTOREDUCTION SURGERY AND HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (CRS/HIPEC) IN GASTRIC CANCER

NCT07178808 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 1480-262
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II treatment study analyzing the role of preoperative chemotherapy, preoperative laparoscopic HIPEC, and gastrectomy with CRS/HIPEC in gastric adenocarcinoma patients with cytology-positive only carcinomatosis, radiologically-occult carcinomatosis, or radiology apparent peritoneal-surface only metastatic disease.

Conditions

Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• To assess improvements in survival in gastric adenocarcinoma patients with occult or apparent carcinomatosis after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

  To determine if preoperative laparoscopic HIPEC and chemotherapy followed by cytoreductive surgery (CRS), gastrectomy and HIPEC in patients with peritoneal surface-only metastasis will improve PFS and/or OS from date of diagnosis of metastatic gastric adenocarcinoma

  From enrollment up to 60 months

Secondary Outcomes (1)

• To study recurrence pattern in patients with recurrence during the study period

  From enrollment up to 60 months

Study Arms (1)

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

EXPERIMENTAL

Patients will undergo cytoreduction \& hyperthermic intraperitoneal chemotherapy

Procedure: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Interventions

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy PROCEDURE

CRS/HIPEC involves aggressive surgical cytoreduction of all visible and palpable tumors, followed by the synergistic use of heated and high dose chemotherapy to address microscopic residual disease.

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age 18 years and above. There will be no upper age restriction. 2)ECOG performance status ≤ 2. (See Appendix A -ECOG Performance Status Scale). 3)Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
• )Adequate renal, and bone marrow function:
• Leukocytes \>= 3,000/uL
• Absolute neutrophil count \>= 1,500/uL
• Platelets \>= 60,000/Ul
• Serum creatinine \<= 1.5 mg/dL 5)Distant metastatic disease of peritoneum may be visualized on imaging:
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• Positive peritoneal cytology only
• Carcinomatosis on diagnostic laparoscopy or laparotomy.

You may not qualify if:

• )Distant metastatic disease not limited to peritoneum:
• Solid organ metastases (liver, central nervous system, lung). 2) Infections such as pneumonia or wound infections that would preclude protocol therapy.
• \) Women with a positive urine or serum pregnancy test are excluded from this study; women ofchildbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
• )Participants with unstable angina or New York Heart Association Grade II or greater congestive heart failure.
• \) Participants deemed unable to comply with study and/or follow-up procedures. 6)Participants with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity.

Sponsors & Collaborators

• Banner Health: lead

Study Sites (1)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

MeSH Terms

Interventions

Cytoreduction Surgical Procedures; Hyperthermic Intraperitoneal Chemotherapy

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 17, 2025
• Study Start: April 16, 2021
• Primary Completion (Estimated): February 22, 2031
• Study Completion (Estimated): February 22, 2031
• Last Updated: May 1, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)