Clinical trial · Interventional
Quintuple Method for Treatment of Multiple Refractory Colorectal Liver Metastases
A Prospective, Single-arm, Single-center, Phase II Clinical Trial to Evaluate the Efficacy of Quintuple Method for the Treatment of Multiple Refractory Colorectal Liver Metastases
- 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)
The aim of this study is to explore the therapeutic effect of Quintuple method in the treatment of patients with multiple and refractory liver metastases from colorectal cancer. A randomized single-arm clinical trial was conducted.The intervention group was treated with single SOX chemotherapy, SOX chemotherapy combined with cetuximab targeted therapy, SOX chemotherapy combined with low-dose cetuximab targeted therapy combined with three-drug regimen（Quintuple method）, and the RECIST 1.1 solid tumor evaluation criteria were used to assess the disease.
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 |
|---|---|---|---|
| For Patients With Colorectal Cancer Liver Metastases Who Were Not Able to Curative Surgical Resection.Focused on the Treatment Effect With the Quintuple Method | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Folic acid | Drug | — | UNRESOLVED |
| Metronidazole | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| S1 | Drug | — | UNRESOLVED |
| Vitamin A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Chemotherapy alone group
- description
- Patients treated with chemotherapy using SOX regimen alone. SOX regimen every 3 weeks,oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area, and tegafur orally on d2-d15 at 20 mg three times daily.
- interventionNames
- Drug: Oxaliplatin
- Drug: S1
- type
- EXPERIMENTAL
- label
- Chemotherapy targeted group
- description
- Patients treated with cetuximab targeted therapy in combination with chemotherapy using SOX regimen.SOX regimen every 3 weeks, oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area, and tegafur orally on d2-d15 at 20 mg three times daily. Cetuximab combined with chemotherapy was administered simultaneously,once every three weeks, and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area.
- interventionNames
- Drug: Oxaliplatin
- Drug: S1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18-80 years at the time of signing the informed consent form; 2. Patients with histologically or cytologically confirmed adenocarcinoma of the colon or rectum (stage IV); 3. Patients with liver metastases found by imaging examination, and liver metastases cannot be radically resected, Or relapse liver metastasis; 4. At least one measurable metastatic lesion as defined by RECIST version 1.1; 5. Genetic test results are Kras/Nras/Braf wild-type or mutation type; 6. ECOG performance status 0-1; 7. Except for the liver, other organs function well; 8. Willingness and ability to comply with scheduled visits, treatment plans,laboratory tests, and other study procedures. Exclusion Criteria: 1. Patients with non-primary intestinal cancer; 2. Patients whose primary tumor as well as metastases can be radically resected by surgery; 3. One or several serious allergies to each drug required for the trial; 4. Combined with respiratory, circulatory, urinary, hematopoietic and other serious underlying diseases.
References
Publications (0)
Data not yet available