The Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Metastatic Adenocarcinoma

NCT06743867 | Recruiting Phase 1 DMC

• 1 other identifier: PIPAC-HOPE-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This research is a prospective, multi-center, single-arm clinical trial aimed at assessing the standard pressurized intraperitoneal aerosol chemotherapy (PIPAC) utilizing a novel nebulized drug delivery system (NDDS) for patients with peritoneal metastatic adenocarcinoma (PMA) originating from gastric, colorectal, appendiceal, or ovarian cancer. The primary objectives of this study are to assess the safety and efficacy of PIPAC with the novel NDDS in the treatment of PMA. Primary endpoints include adverse events (AEs) and serious AEs, as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, incidences of device defects, postoperative pain scores evaluated using the Visual Analogue Scale / Score (VAS), and quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 scale, Version 3.0). Secondary endpoints include the intra-abdominal peritoneal cancer index (PCI), peritoneal regression grading score (PRGS), objective response rate (including partial response (PR) and complete response (CR)), improvement in ascites, conversion rate (patients proceeding to cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) following initial PIPAC treatments), progression-free survival (PFS), and overall survival (OS).

Conditions

Peritoneal Carcinoma Metastatic

Outcome Measures

Primary Outcomes (4)

• Adverse Events (AE) and serious AE associated with Treatment

  Treatment-related adverse events are categorized according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Elevated grades correlate with increased severity of adverse events

  4-6 weeks following the initial and secondary PIPAC procedures, and 6 months subsequent to the tertiary PIPAC procedure

• Incidences of device defects

  Incidences of device defects during PIPAC therapy

  During each PIPAC therapy

• Postoperative pain scores

  Postoperative pain is assessed using the Visual Analogue Scale/Score (VAS), which integrates the Wong-Baker Faces Pain Scale Revision (FPS-R) and the Numerical Rating Scale (NRS). Scores vary from 0 to 10, with 1-3 indicating "mild pain (sleep unaffected)", 4-6 indicating "moderate pain (sleep disruption)", and 7-10 indicating "severe pain (severe sleep disruption)".

  The first to seventh day after the PIPAC procedure

• Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Version 3.0)

  The quality of life is assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 scale, Version 3.0). A higher comprehensive score indicates superior quality of life.

  4-6 weeks following the initial and second PIPAC procedures, and 6 months subsequent to the third PIPAC procedure

Secondary Outcomes (7)

• Intra-abdominal peritoneal cancer index (PCI)

  During each PIPAC procedure

• Peritoneal regression grading score (PRGS)

  During each PIPAC procedure

• Objective response rate (partial and complete response)

  Within 6 months after the third PIPAC procedure

• Improvement in ascites

  During each PIPAC procedure

• Conversion rate

  4-6 weeks following the initial and secondary PIPAC procedures, and 6 months after the tertiary PIPAC procedure

Study Arms (1)

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)

EXPERIMENTAL

Drug: Pressurized Intraperitoneal Aerosol Chemotherapy

Drug: Pressurized Intraperitoneal Aerosol Chemotherapy

Interventions

Pressurized Intraperitoneal Aerosol Chemotherapy DRUG

The comprehensive therapeutic strategy will be modified based on the integrated 2- or 3-week systemic chemotherapies. In the interim, a total of three PIPAC procedures will be conducted for all qualifying patients. 1. PIPAC combined with 2-week systemic chemotherapies: PIPAC therapy will occur every four weeks, while systemic chemotherapies will be administered during the first and third weeks following the initial and second PIPAC procedures respectively. 2. PIPAC combined with 3-week systemic chemotherapies: (1) Scheme 1: PIPAC therapy will occur every 6 weeks, with systemic chemotherapies administered during the 1st and 4th weeks following the first and second PIPAC procedures, respectively. (2) Scheme 2: PIPAC therapy will occur every 6 weeks, while systemic chemotherapies will be administered in the 2nd and 5th weeks following the initial and second PIPAC procedures, respectively.

Also known as: Systemic chemotherapy

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathology verified that peritoneal metastatic adenocarcinoma (PMA) arises from gastric, colorectal, appendiceal, or ovarian carcinoma;
• Applicable to individuals of either sex, aged between 18 and 75 years;
• Eastern Cooperative Oncology Group (ECOG) scale ≤ 2;
• Absence of other concurrent malignancies;
• Without contraindications for laparoscopic surgery;
• Laboratory testing: blood routine examination: neutrophil count ≥ 1.5× 10\^9/L, platelet count ≥ 80 × 10\^9/L, hemoglobin ≥ 80g/L ; blood biochemistry: serum total bilirubin ≤ 1.5 ×ULN, Alanine transaminase and aspartate aminotransferase ≤ 2.5 ×ULN, serum creatinine ≤ 1.5 ×ULN;
• Life expectancy \> 6 months;
• Informed consent understood and signed.

You may not qualify if:

• Presenting symptoms of gastrointestinal obstruction;
• Fully reliant on parenteral nutrition;
• Exhibiting decompensated ascites;
• Suffering from severe abdominal infection (indications of peritonitis);
• Characterized by extensive adhesions in the abdominal cavity;
• Concurrently undergoing cytoreductive surgery (CRS) or gastrointestinal tract resection and reconstruction procedures;
• With portal vein thrombosis;
• Concurrently, individuals with significant or unmanaged medical conditions or infections (including atrial fibrillation, angina, cardiac dysfunction, ejection fraction \< 50%, refractory hypertension etc.);
• Previous chemotherapeutic drugs allergy;
• Severe cardiopulmonary, hepatonephric, hematologic, and metal diseases, or drug abuse;
• Pregnancy or lactating women;
• Engage in additional clinical trials within three months preceding recruitment;
• Other conditions: patients are inappropriately included as determined by researchers.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Tianjin Third Central Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Second Affiliated Hospital of Guangzhou Medical University: collaborator
• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine: collaborator
• Henan Cancer Hospital: collaborator
• Tongji Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Jiangxi Provincial Cancer Hospital: collaborator
• The First Affiliated Hospital of Air Force Medicial University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Southern Medical University, China: collaborator
• Affiliated Hospital of Qinghai University: collaborator
• Ruijin Hospital: collaborator
• Shenzhen Second People's Hospital: collaborator
• West China Hospital: collaborator
• Tianjin Nankai Hospital: collaborator
• Wannan Medical College Yijishan Hospital: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Changzhi People's Hospital: collaborator
• First Hospital of China Medical University: collaborator
• Xiangya Hospital of Central South University: collaborator
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• Sun Yat-sen University: collaborator
• Fujian Medical University Union Hospital: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Yong Li, M.D., Ph.D.

CONTACT

+86 13822177479; liyong@gdph.org.cn

Liming Yao

CONTACT

+86 020-83525975; Yaoliming@gdph.org.cn

Study Design

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

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 20, 2024
• Study Start: December 11, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

CN (1)