Hyperthermic Intraperitoneal Chemotherapy for Advanced Gastric Cancer With Peritoneal Metastatis

NCT03604614 | Unknown Phase 2 DMC

• 1 other identifier: GDPHCM-GI-03
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence rate of gastric cancer is high in Southeast Asia, so is the mortality rate.Due to the lack of specific performance, about 5%-20% of patients have found peritoneal metastases at the time of first diagnosis.At present, clinical studies on HIPEC in the treatment of patients with advanced gastric cancer peritoneal metastasis are almost related to abdominal perfusion after laparoscopic gastrectomy.Herein, we conduct a single-centre randomized controlled trial to explore the safety and feasibility of laparoscopic exploration combined with HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis.

Conditions

Stage IV Gastric Cancer With Metastasis; Hyperthermic Intraperitoneal Chemotherapy; Exploratory Behavior

Keywords

peritoneal metastatis; Hyperthermic Intraperitoneal Chemotherapy; Advanced gastric adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival

  From date of randomization until the date of first documented progression or date of death for tumor cause, whichever came first, assessed 7 months

Secondary Outcomes (3)

• 1-year survival

  one year

• Ascites assessment

  Intraoperative

• Median survival

  From date of randomization until only 50% of individuals living for tumor cause, assessed 2 years

Study Arms (2)

HIPEC and chemotherapy

EXPERIMENTAL

Hyperthermic Intraperitoneal Chemotherapy and SOX（Tiggio+Oxaliplatin ）

Drug: Hyperthermic Intraperitoneal Chemotherapy

Without HIPEC

SHAM COMPARATOR

Without Hyperthermic Intraperitoneal Chemotherapy，Only SOX（Tiggio+Oxaliplatin ）

Drug: Without Hyperthermic Intraperitoneal Chemotherapy

Interventions

Hyperthermic Intraperitoneal Chemotherapy DRUG

The investigators use Paclitaxel as peritoneal hyperthermic perfusion chemotherapy drugs，75mg/m2 for the first time，50mg/m2 for the second time and third time.The chemotherapy is SOX(Tiggio d1-d14 bid po and Oxaliplatin 130mg/m2 ivd d1 qd).The Tiggio dosage depends on the patient's body surface area, body surface area \<1.25m2 40mg/time, 1.25-1.50m2 50mg/time, \>1.50m2 60mg/time.

HIPEC and chemotherapy

Without Hyperthermic Intraperitoneal Chemotherapy DRUG

The chemotherapy is SOX(Tiggio d1-d14 bid po and Oxaliplatin 130mg/m2 ivd d1 qd).The Tiggio dosage depends on the patient's body surface area, body surface area \<1.25m2 40mg/time, 1.25-1.50m2 50mg/time, \>1.50m2 60mg/time.

Without HIPEC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary gastric adenocarcinoma diagnosed pathologically by endoscopic biopsy；
• Laparoscopic exploration of patients with advanced gastric adenocarcinoma of peritoneal metastasis；
• Eastern Cooperative Oncology Group (ECOG): 0 ot 1；
• American Society of Anesthesiologists （ASA） score: I to Ⅲ；
• Patient informed consent。

You may not qualify if:

• Pregnancy or female in suckling period；
• Severe mental illness；
• Preoperative imaging or intraoperative exploration reveals distant blood, liver, lung, and brain metastases；
• years of history of other malignant diseases；
• A history of unstable angina or myocardial infarction within 6 months；
• History of cerebral infarction or cerebral hemorrhage within 6 months；
• A history of sustained systemic corticosteroid treatment within 1 month；
• Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor；
• Pulmonary function test FEV1 \<predicted value 50%。

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

• Luo L, Zhang Z, Zeng H, Xu Y, Peng Y, Huang H, Lin Z, Xiong W, Wang W. Hyperthermic intraperitoneal chemotherapy plus SOX chemotherapy versus SOX chemotherapy alone in patients with gastric cancer and peritoneal metastasis: a phase II randomized clinical trial. J Gastrointest Oncol. 2025 Feb 28;16(1):17-26. doi: 10.21037/jgo-24-807. Epub 2025 Jan 9.

  PMID: 40115934 DERIVED

MeSH Terms

Conditions

Exploratory Behavior

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Wei Wang

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Wenjun Xiong

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Wang, M.D., PH.D.

CONTACT

+86-13922255515; wangwei16400@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wei Wang M.D., PhD.，Head of Gastroenterology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 27, 2018
• Study Start: June 1, 2017
• Primary Completion: August 24, 2017
• Study Completion: August 24, 2020
• Last Updated: July 27, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)