NCT06311916Not yet recruitingPhase 4
Efficacy and Safety of Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model.
Efficacy and Safety of Neoadjuvant HAIC Combined With Immunotherapy and Targeted Therapy in Patients With Resectable Intermediate-stage HCC Screened by a Multimodal Deep Learning Model: a Multicenter Randomized Controlled Trial.
Source: ClinicalTrials.gov · Last updated 15 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Primary liver cancer is one of the most common malignant tumors in the world, and more than 90% of primary liver cancers are pathologically characterized as hepatocellular carcinoma (HCC). The intermediate stage (BCLC-B) HCC is highly heterogeneous, and there is no consensus on the treatment of this stage of the tumor in Western and Eastern countries. New tools are urgently needed to guide the choice of treatment options for patients with this stage of the tumor in order to reduce the risk of postoperative recurrence and the overall survival rate.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 312 (estimated)
- First submitted
- 9 Mar 2024
- Start date
- 1 May 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Chen Xiaoping
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06311916
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 312
- From 1 May 2024 to the primary completion date, 31 Dec 2027
- 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 distribution in two liver lobes, diffuse growth, or other reasons why radical R0 resection is not possible.
- A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication/esophageal varices), as determined by the investigator.
Other illness
- Active infection.
Lab values
- Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.).
- Other significant clinical and laboratory abnormalities that affect the safety evaluation.
Other
- Pregnant and lactating women.
- Inability to follow the study protocol for treatment or follow up as scheduled.
Who the study is looking for
- Aged 18-75.
- No previous local or systemic treatment for hepatocellular carcinoma.
- Child-Pugh liver function score ≤ 7.
- ECOG PS 0-1.
- No serious organic diseases of the heart, lungs, brain, kidneys, etc.
- Enhanced MRI determines that the tumor stage is intermediate (BCLC stage B) and is safe for radical hepatectomy.
- Pathologic type of hepatocellular carcinoma confirmed by puncture biopsy.
- Multimodal Deep Learning Model Screening Based on Pathology, Imaging, and Genetic Data Suggests Benefit from HAIC in Combination with Lenvatinib and PD-1 inhibitors.
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.