NCT05750329Not yet recruiting
Liver Transplantation With Two-stage Liver Resection in Unresectable Liver Cancer , Metastases or Emd-stage Liver Disease (LTLR-LC)
Clinical Study of Adjuvant Liver Transplantation Combined With Two-stage Hepatectomy for the Treatment of Patients With Unresectable Primary Hepatocellular Carcinoma, Colorectal Cancer With Liver Metastases, or End-stage Liver Disease: a Multicenter, Prospective, Single-arm Study
Source: ClinicalTrials.gov · Last updated 7 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Colon cancer and primary liver cancer are common malignant tumors with low survival rate worldwide, and unresectable primary liver cancer and colon cancer liver metastases have worse prognosis. End-stage liver disease is equated with advanced liver disease, liver failure and decompensated cirrhosis because they are generally irreversible. Liver transplantation is a treatment option for the above-mentioned patients and is expected to improve the prognosis of the patients, but the biggest problem faced by such patients is the shortage of donor livers. Recently, a new surgical modality, resection and partial liver segment 2-3 transplantation with delayed total hepatectomy (RAPID), can greatly alleviate these problems.Based on clinical surgical experience, our center proposes and designs a clinical study of adjuvant liver transplantation combined with two-stage hepatectomy in the treatment of patients with unresectable primary liver cancer, colorectal cancer liver metastases, or end-stage liver disease. By improvement of RAPID operation, the safety and efficacy of this treatment method in patients with those disease were evaluated.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 4 Jan 2023
- Start date
- Aug 2023
- Primary completion date
- Aug 2026
- Lead sponsor
- RenJi Hospital
- NCT number
- NCT05750329
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Aug 2023 to the primary completion date, Aug 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Tumor progression during chemotherapy or important comorbidities that affect surgery
- Anatomical abnormalities that preclude liver transplantation
Other illness
- Uncorrectable cardiopulmonary disease with high surgical risk
- Combined with other diseases such as AIDS that affect surgery or tumor progression
Other
- Extrahepatic tumor burden (except for resectable lung metastases) and/or macrovascular tumor infiltration
- Persistent non-compliance with medical care
Who the study is looking for
- aged 18-75 years;
- patients with unresectable primary hepatocellular carcinoma or colorectal cancer with liver metastases who also meet the following criteria: tumor shrinkage (still unresectable) or no significant progression after a first-line chemotherapy regimen of 6-8 weeks; no other abdominal metastases or 1-3 resectable pulmonary metastases;
- patients with end-stage liver disease;
- preoperative Child classification of A or B, able to tolerate the subsequent surgical program
- Signed informed consent Note: One of the second or third criteria needs to be fulfilled and all the rest of the selection criteria need to be fulfilled
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.