NCT06988852 FOLFOX-HAIC as Conversion Treatment for Initially Unresectable Colorectal Liver Metastasis
| NCT ID | NCT06988852 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tongji Hospital |
| Condition | Colorectal Liver Metastasis (CRLM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2023-05-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Try FOLFOX-HAIC combining bevacizumab or cetuximab for initially unresectable colorectal liver metastasis patients to increase the conversion to resection rate to improve long-term survival outcomes
Eligibility Criteria
Inclusion Criteria: * age 18-75 years * no history of other malignant diseases * refuse or progress in prior systemic treatment * diagnosed as CRLM confirmed by pathology, in spite of whether the primary tumor had been resected * at least one lesion in the liver could be measured * left ventricular ejection ≥45%, forced expiratory volume in one second/forced vital capacity≥60% and Eastern Cooperative Oncology Group (ECOG) score of 0-1 * Child-Pugh class A * adequate organ function, i.e.: white blood cell (WBC) ≥3.0×109/L, neutrophils ≥1.5×109/L, platelet (PLT) ≥75×109/L, total bilirubin ≤30μmol/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤200U/L, creatinine ≤150μmol/L Exclusion Criteria: * extra-hepatic metastasis verified by medical imaging * unable to tolerate chemotherapy, anesthesia or surgery * allergy or previous intolerable to any agent of oxaliplatin, leucovorin, 5-Fu, bevacizumab or cetuximab * tumor spread in abdomen * cerebral infarction, cerebral hemorrhage, gastrointestinal hemorrhage/perforation within 6 months, coagulation disorders and gastrointestinal ulcer * primary tumor may not be completely resected * prior treatment of CRLM with resection, ablation or radiation * incomplete clinical or follow-up data
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06988852 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colorectal Liver Metastasis (CRLM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06988852 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06988852 currently recruiting?
Yes, NCT06988852 is actively recruiting participants. Contact the research team at bixiangzhang@hust.edu.cn for enrollment information.
Where is the NCT06988852 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06988852 clinical trial?
NCT06988852 is sponsored by Tongji Hospital. The trial plans to enroll 300 participants.