Clinical trial · Interventional
HIPEC and Systemic Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer
A Study of Conversion Therapy Using Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) and Systemic Oxaliplatin/Capecitabine Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No enrolled patients received the second surgery.
Summary
Brief summary (as posted)
The prognosis of patients with unresectable peritoneal metastases from colorectal cancer is poor. These patients may obtain survival benefit from radical colorectal resection and cytoreductive surgery (CRS). The response rates of previous conversion therapy are low. Hyperthermic intraperitoneal chemoperfusion (HIPEC) and systemic chemotherapy are effective methods of reducing peritoneal cancer index (PCI) levels. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Metastases From Colorectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exploratory laparoscopy or laparotomy | Procedure | — | UNRESOLVED |
| HIPEC | Procedure | — | UNRESOLVED |
| Systemic chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- HIPEC with Raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week Oxaliplatin/Capecitabine chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.
- interventionNames
- Procedure: exploratory laparoscopy or laparotomy
- Procedure: HIPEC
- Drug: Systemic chemotherapy
Primary outcomes (1)
- measure
- radical resection rate
- timeFrame
- 3 months
- description
- The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histological proved diagnosis of colorectal cancer. * Unresectable peritoneal metastases and primary tumor proved at surgery. * No evidence of distant metastases. * Have not received radiotherapy, chemotherapy or immunotherapy. * ECOG score: 0\~2. * Written informed consent is obtained prior to commencement of trial treatment. Exclusion Criteria: * Existence of distant metastasis outside the abdomen. * Any previous radiotherapy, chemotherapy or immunotherapy. * Active systemic infections. * Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial. * Female patients who are pregnant or breast feeding
References
Publications (0)
Data not yet available