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Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin

ConditionHCC - Hepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

Postoperative recurrence remains a major limitation to long-term survival in hepatocellular carcinoma (HCC). In addition, a narrow surgical margin is widely regarded as a risk factor for recurrence. Neoadjuvant therapy may represent a strategy to reduce the risk of recurrence, thereby improving long-term outcomes. Tislelizumab plus lenvatinib has demonstrated promising efficacy with manageable safety in advanced HCC. Therefore, we will conduct a phase II study to compare neoadjuvant tislelizumab plus lenvatinib followed by surgery versus surgery alone in patients with stage IA HCC and an anticipated narrow surgical margin.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient voluntarily participates in this study and provides written informed consent.

Age ≥18 years at the time of consent; male or female.

Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.

Child-Pugh class A hepatic function.

Disqualifiers

Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed-cell carcinoma, or fibrolamellar carcinoma; any other active malignancy concurrent with HCC or within the past 5 years, except for definitively treated localized tumors (e.g., basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ).

Planned or prior solid-organ transplantation or allogeneic bone marrow transplantation (corneal transplantation is allowed).

Known hypersensitivity to macromolecular protein products, or known allergy to any excipients of tislelizumab.

Any active autoimmune disease or a history of autoimmune disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tislelizumab

    Drug

    Tislelizumab, 200mg, IV, q3w. Treatment will be given in 3-week cycles for a total of 2 cycles.

  • Lenvatinib

    Drug

    Lenvatinib, 8mg for BW\<60kg or 12mg for BW≥60kg, PO, qd. Treatment will be given in 3-week cycles for a total of 2 cycles.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Arm ANo intervention 0 interventions
Group B: Arm BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

1-year RFS

Time frame
1 year after surgery

Secondary outcomes

1

ORR

Time frame
6 weeks after randomization
2

DCR

Time frame
6 weeks after randomization
3

MPR

Time frame
10 weeks after randomization
4

Incidence of Microvascular invasion (MVI)

Time frame
10 weeks after randomization

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: