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New treatment option for Hepatocellular Carcinoma
Official title Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1 for High-risk Recurrent HCC
ClinicalTrials.gov ID: NCT06467799
What this study is testing
What is Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1?
Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Surgical resection is the primary curative treatment for patients with hepatocellular carcinoma (HCC), with a 5-year overall survival rate of 60-80% post-surgery. Therefore, guidelines recommend surgical resection as the first-line choice for early to mid-stage HCC (CNLC stages IA-IIA or BCLC stages A/B) patients with well liver reserve function.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Newly diagnosed and untreated hepatocellular carcinoma (clinical diagnostic criteria based on the " Chinese Guidelines for the Diagnosis and...
- Tumor staging: beyond Milan criteria (single tumor \>5 cm, or 2-3 tumors with the largest diameter \>3 cm), resectable CNLC stage Ib/IIa...
- No tumor thrombus, distant metastasis, or lymph node metastasis;
- Normal liver volume ≥ 700 cc, estimated residual liver volume \>40% after resection;
- Patient KPS ≥ 90;
You likely can't join if
- Combined with severe impairment of functions of other important organs such as heart, lungs, and kidneys; active infections other than viral...
- Contraindications to surgical resection and immunotherapy;
- History of other malignant tumors;
- Combined with immunological diseases or other conditions requiring long-term steroid treatment;
- Known or suspected allergy to the study drug or any drugs administered in connection with this trial;
- History of organ transplantation;
See the full eligibility criteria
- Newly diagnosed and untreated hepatocellular carcinoma (clinical diagnostic criteria based on the " Chinese Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2024 Edition) " formulated by the...
- Tumor staging: beyond Milan criteria (single tumor \>5 cm, or 2-3 tumors with the largest diameter \>3 cm), resectable CNLC stage Ib/IIa hepatocellular carcinoma;
- No tumor thrombus, distant metastasis, or lymph node metastasis;
- Normal liver volume ≥ 700 cc, estimated residual liver volume \>40% after resection;
- Patient KPS ≥ 90;
- Liver function Child-Pugh class A;
- Estimated survival of more than 6 months;
- Function of important organs meets the following requirements: white blood cells ≥ 4.0×10\^9/l, neutrophils ≥ 1.5×10\^9/l, platelets ≥ 80.0×10\^9/l, hemoglobin ≥ 90 g/l; serum albumin ≥ 2.8 g/dl; total bilirubin ≤ 1.5 ×...
- The subject must be able to understand and voluntarily sign a written informed consent form, and must sign the informed consent form prior to any specific procedure of the study, agreeing to comply with the medication...
- Combined with severe impairment of functions of other important organs such as heart, lungs, and kidneys; active infections other than viral hepatitis or other serious comorbid conditions, making the patient unable to...
- Contraindications to surgical resection and immunotherapy;
- History of other malignant tumors;
- Combined with immunological diseases or other conditions requiring long-term steroid treatment;
- Known or suspected allergy to the study drug or any drugs administered in connection with this trial;
- History of organ transplantation;
- Pregnant or breastfeeding women;
- Other factors that may affect patient enrollment and assessment outcomes;
- Refusal to follow-up according to the requirements set by the study protocol, and refusal to sign the informed consent form.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.