Clinical trial · Interventional
Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)
Multicenter, Randomized Controlled Trial Designed to Evaluate the Efficacy and Safety of Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Raltitrexed or Oxaliplatin Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)
NCT02965248CI-TRIAL-00033349unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to evaluate the efficacy and safety of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed or oxaliplatin versus no HIPEC in locally advanced 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 |
|---|---|---|---|
| Locally Advanced Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatin | Procedure | — | UNRESOLVED |
| Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed | Procedure | — | UNRESOLVED |
| Standard adjuvant systemic chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Patients undergo radical resection of colorectal cancer (open/laparoscopic) and receive standard adjuvant systemic chemotherapy comprising mFOLFOX6/CapeOx/sLV5FU2/Cape. Systemic chemotherapy will continue for 6 months.
- interventionNames
- Drug: Standard adjuvant systemic chemotherapy
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Patients undergo radical resection of colorectal cancer (open/laparoscopic) and receive standard adjuvant systemic chemotherapy comprising mFOLFOX6/CapeOx/sLV5FU2/Cape. Systemic chemotherapy will continue for 6 months. Patients also undergo HIPEC with raltitrexed (3mg/m2) intraperitoneally for 60 minutes during surgery or within 10 days after the operation.
- interventionNames
- Drug: Standard adjuvant systemic chemotherapy
- Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Joined the study voluntarily and signed informed consent form * Eastern Cooperative Oncology Group performance status of 0 to 1 * Life expectancy of more than 5 years * Colorectal adenocarcinoma / mucinous adenocarcinoma / signet ring cell cancer confirmed by histopathology * Stage T4NanyM0 cancer; or stage T3NanyM0 mucinous adenocarcinoma / signet ring cell cancer / adenocarcinoma with partly mucinous adenocarcinoma or signet ring cell cancer * R0 resection of colorectal cancer * Neutrophils (ANC) ≥ 1.5×10\^9/L, Platelet count (Pt) ≥ 100× 10\^9/L, Hemoglobin (Hb) ≥ 80 g/L, Hepatic function: ALT and AST ≤ 2.5 times upper limit of normal (ULN) and TBIL ≤ 1.5 times ULN, Renal function: creatinine ≤ 1.5 times ULN * Use of an effective contraceptive for adults to prevent pregnancy Exclusion Criteria: * Rectal cancer below peritoneal reflection (≤ 8cm above the anal verge) * Other malignant tumors within the past 5 years, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived from radical treatment * Severe adhesion of peritoneal cavity impossible to separate * Abdominal infection * Allergic to raltitrexed, 5-FU, and oxaliplatin; Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency * Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior * Drug addiction, Alcoholism or AIDS * Impossible to tolerate the operation due to severe cardiac, lung, and vascular diseases * Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
References
Publications (0)
Data not yet available
No reference posted for this study.