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HCCNCT06069947

SALT for Liver Cirrhosis With HCC

A study testing sequential adult left lateral lobe liver transplantation (SALT) in people with HCC and Liver Cirrhosis, run by RenJi Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

HCC is the third leading cause of cancer deaths worldwide. Although surgical treatment may be effective in patients with HCC, the five-year survival rate is only 50-70%. Moreover, due to the lack of early diagnostic marker, most patients with HCC are often diagnosed in an advanced stage with poor prognosis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HCC, Liver Cirrhosis
What is being tested?
sequential adult left lateral lobe liver transplantation (SALT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
20 Oct 2023to 30 Jun 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75;
  • Child-Pugh A-B ;
  • liver cirrhosis with Heoatocellular Carcinoma (HCC) with Hepatitis B virus infection 4. Patients with Heoatocellular Carcinoma (HCC) meets the "up to seven" criteria: the sum of tumour size and tumour numbers does not exceed 7;
  • 5. Performance Status 0-1; 6. Sign the informed consent form.

Who cannot join

  • Combined with the main portal vein tumor thrombus, the main vena cava tumor thrombus and common bile duct tumor thrombus;
  • Combined with severe hepatic encephalopathy ;
  • Combined with pulmonary hypertension(high-risk or middle-risk, WHO grade: III-IV);
  • Special types of anatomical variations(such as portal vein classification: type III and type IV, etc. );
  • Extrahepatic tumor burden;
  • Cardiopulmonary disease or severe infection or Cerebral Vascular Disease that cannot be corrected, with high surgical risk, that makes liver transplantation impossible;
  • Psychological or social conditions may interfere with the patient's participation in the study or evaluation of the study results;
  • Other reasons that the researchers think are not suitable for participation.

About this study

Official title: Sequential Adult Left Lateral Lobe Liver Transplantation (SALT) in Patients With Liver Cirrhosis With Hepatocellular Carcinoma(HCC): a Single-center, Prospective, Single-arm Study

HCC is the third leading cause of cancer deaths worldwide. Although surgical treatment may be effective in patients with HCC, the five-year survival rate is only 50-70%. Moreover, due to the lack of early diagnostic marker, most patients with HCC are often diagnosed in an advanced stage with poor prognosis. Therefore, there is an urgent need to further understand the possible aetiological factors and surgical treatment methods to improve the prognosis of patients with HCC. Liver transplantation is an ideal choice for patients with liver cirrhosis with HCC, which can significantly improve the postoperative survival rate. But the most serious problem facing such patients is the shortage of donor livers. In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment (2-3 segment) transplantation combined with delayed total hepatectomy can greatly alleviate the shortage of liver donors in the above-mentioned patients. Based on the experience of clinical operation, our center proposes and designs a clinical study of sequential adult left lateral lobe liver transplantation (SALT) for the treatment of patients with liver cirrhosis with HCC. On the basis of RAPID, the safety and efficacy of sequential adult left lateral lobe liver transplantation were evaluated for the above patients.

Read the detailed description

Heoatocellular carcinoma (HCC) ranks sixth in the incidence of malignant tumors and fourth in case fatality in the world. In China, liver cancer deaths account for the second largest cause of all cancer deaths. Surgical resection of liver cancer is still the main treatment, but the five-year survival rate is only 50%-70%. Liver transplantation can remove tumours and the underlying liver disease at the same time, and has become an important means for the radical treatment of liver cancer.

Liver transplantation for liver cancer is a tortuous process. The original intention of liver transplantation was to treat "unresectable liver cancer", but due to the high recurrence rate and metastasis rate of postoperative tumors, many centers list liver cancer as a contraindication to liver transplantation. In 1996, Mazzaferro et al. proposed the Milan criteria, and patients with liver cancer patients has a 4-year survival rate of 85% after liver transplantation. However, the Milan criteria was too strict and excluded a large number of patients with liver cancer who were likely to survive for a long time through liver transplantation. Therefore, the UCSF standard was proposed in 2001, and the small relaxation was made on the basis of the Milan criteria, and the survival rate was similar to the Milan criteria. In China, hepatitis B virus infection accounts for the vast majority of liver cancer patients, and the race, liver cancer incidence and treatment concept are different from European and American countries, and many factors indicate that it is urgent to formulate liver transplantation criteria that meet China's national conditions. In 2006, the Shanghai Fudan criteria was proposed based on the clinical data of liver transplant patients in China, which further expanded the scope of indications for liver transplantation of liver cancer, and did not reduce the overall survival rate and tumor-free survival rate of patients after surgery, and was also verified in the Western population. Since then, Kyoto standards, Hangzhou standards, Up-To Seven standards, and Toronto standards have been proposed around the world. These criteria have been relaxed to varying degrees in the size and number of tumors. At present, except for the Milan criteria and UCSF criteria, other standards have not been uniformly recognized.

However, it is difficult for patients with cirrhosis with hepatocellular carcinoma (cHCC) to enroll in the above transplant criteria, and many patients lose the opportunity to obtain liver transplantation, so the biggest problem faced by patients with cirrhosis and hepatocellular carcinoma is the shortage of donor liver. Also, cirrhosis with hepatocellular carcinoma is often considered a contraindication to liver transplantation, making it more difficult to obtain a donor liver.

Therefore, expanding the donor liver pool is urgently needed for the treatment of patients with patients with liver cirrhosis with HCC. In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment 2-3 transplantation with delayed total hepatectomy (RAPID) . This approach allows transplantation of the left liver (segments 2+3) to an adult recipient, while the remaining enlarged right hemi-liver is transplanted to another adult recipient, effectively avoiding some unsuitable left lateral lobe livers for pediatric recipients to be wasted. Recipients who received right-hemi-liver transplantation had a similar prognosis compared with those who received whole-liver transplantation. Therefore, if the RAPID technique is confirmed to be feasible, it can greatly alleviate the shortage of liver donors. In addition to cadaver sources, living adult donors can also be considered as the source of liver donors. A smaller left lateral lobe donor liver also places less burden on the donor than a left or right hemiliver.

To sum up, our center proposed and designed a clinical study of sequential adult left lateral lobe liver transplantation (SALT) in the treatment of patients with liver cirrhosis with HCC based on clinical surgical experience. On the basis of RAPID surgery, the overall survival rate of patients with liver cirrhosis with HCC was evaluated by SALT.

Conditions
HCC, Liver Cirrhosis
Being tested
sequential adult left lateral lobe liver transplantation (SALT)
Keywords
Hepatocellular Carcinoma, Liver cirrhosis, Liver transplantation, Two-stage liver resection
Medical subject headings
Liver Cirrhosis, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sequential adult left lateral lobe liver transplantation (SALT)Procedure or surgery

    Hemihepatectomy combined with left lateral lobe liver transplantation was performed first, and residual liver resection was performed after the graft grew to a sufficient functional liver volume.

Study groups in NCT06069947
Study groupRoleWhat they receive
Surgical groupExperimentalSALT operation plan for patients who meet the enrollment conditions and successfully match the donor liver: Hemihepatectomy combined with left lateral lobe liver transplantation was performed first, and residual liver resection was performed after the graft grew to a sufficient functional liver volume.
Receives: Procedure: sequential adult left lateral lobe liver transplantation (SALT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival(OS)

    To describe overall survival in patients with liver cirrhosis with HCC treated with sequential adult left lateral lobe liver transplantation.

    Measured: 3 years after the second liver resection

Secondary outcomes (1)
  1. Disease-free survival,DFS

    Describe the tumor-free survival period of SALT in the treatment of patients with liver cirrhosis with HCC

    Measured: 1 month, 3 months, 6 months, 1 year, 2 years and 3 years post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2023
  2. Study start20 Oct 2023 (estimated)
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
SALT operation plan for patients who meet the enrollment conditions and successfully match the donor liver: Hemihepatectomy combined with left lateral lobe liver transplantation was performed first, and residual liver resection was performed after the graft grew to a sufficient functional liver volume.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06069947
Sponsor's protocol ID
LY2023-185-C
Status last verified
Oct 2023
First submitted
22 Sep 2023
Last updated
6 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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