Radiotherapy Delays Second-line Drug Therapy for Oligo Progressive Primary Liver Cancer

NCT ID: NCT06261047

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-01-01

Brief Summary

Recent years have seen significant advancements in the treatment landscape of advanced hepatocellular carcinoma (HCC), with the emergence of targeted and immunotherapy strategies reshaping first-line therapy. Sorafenib, a multi-targeted tyrosine kinase inhibitor, initially set the standard, followed by approvals for lenvatinib, regorafenib, cabozantinib, and ramucirumab. Immunotherapy, particularly combinations like atezolizumab with bevacizumab, has shown superior efficacy over sorafenib. Despite these advances, second-line therapies offer limited progression-free survival (mPFS: 2-3 months), necessitating new approaches. Radiotherapy, bolstered by technological advancements, has shown promise. Techniques like stereotactic body radiotherapy (SBRT) combined with PD-1 inhibitors achieve significant response rates and survival benefits. Combining radiotherapy with targeted immunotherapy has also demonstrated improved outcomes. Radiotherapy, especially in oligometastatic HCC, is increasingly favored due to its ability to enhance local control without increasing toxicity. These developments underscore the evolving landscape of HCC treatment towards personalized and multimodal approaches.

Detailed Description

hepatocellular carcinoma, stage IIIb, oligo progression

Conditions

Hepatocellular Carcinoma; Radiotherapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

radiotherapy

radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Obtain written informed consent before implementing any trial-related procedures.
• Male or female, aged 18 years or older, and 75 years or younger.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.
• Histological or cytological confirmation of primary hepatocellular carcinoma (HCC), or diagnosed according to the Clinical Diagnosis and Treatment Guidelines for Primary - Liver Cancer (2019 edition) issued by the National Health Commission of the People's Republic of China.
• Tumor staged as BCLC stage C; patients have ≤5 lesions (≤3 affected organs) with oligometastasis or oligoprogression.
• Liver function assessed by Child-Pugh score ≤7 points.
• Availability of tumor samples for biomarker assessment.
• Stable disease with systemic therapy for ≥3 months and an anticipated survival period of ≥6 months.

Exclusion Criteria

• Diagnosis of malignancy other than liver cancer within 3 years before enrollment (excluding curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma).
• Currently participating in interventional clinical research treatment, or received other investigational drugs or investigational device therapy within the past 4 weeks before enrollment.
• Received traditional Chinese medicine or immunomodulatory drugs with anti-tumor indications within 2 weeks before enrollment (including thymosin, interferon, interleukin, except for local use to control pleural effusion).
• Experienced active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressive agents) within 2 years before enrollment. Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatment.
• Received radiotherapy within 2 weeks before enrollment.
• HIV +
• Active untreated hepatitis B (defined as HBsAg positive with HBV-DNA copy number exceeding the upper limit of normal value in the laboratory of the participating center).
• Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Jinbo Yue

jinbo Yue

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

jibo yue, dorctor

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Locations

Jinbo Yue

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

jinbo yue, dorctor

Role: CONTACT

yuejinbo@hotmail.com

+86053167626442

lei xu

Role: CONTACT

Len.Xu@hotmail.com

+86053167626442

Facility Contacts

jinbo yue

Role: primary

yuejinbo@hotmail.com

+86053167626442

References

Hepatocellular carcinoma. Nat Rev Dis Primers. 2021 Jan 21;7(1):7. doi: 10.1038/s41572-021-00245-6. No abstract available.

Reference Type: RESULT

PMID: 33479233 (View on PubMed)

Lee S, Kang TW, Song KD, Lee MW, Rhim H, Lim HK, Kim SY, Sinn DH, Kim JM, Kim K, Ha SY. Effect of Microvascular Invasion Risk on Early Recurrence of Hepatocellular Carcinoma After Surgery and Radiofrequency Ablation. Ann Surg. 2021 Mar 1;273(3):564-571. doi: 10.1097/SLA.0000000000003268.

Reference Type: RESULT

PMID: 31058694 (View on PubMed)

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Reference Type: RESULT

PMID: 29433850 (View on PubMed)

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Reference Type: RESULT

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Zhu AX, Finn RS, Edeline J, Cattan S, Ogasawara S, Palmer D, Verslype C, Zagonel V, Fartoux L, Vogel A, Sarker D, Verset G, Chan SL, Knox J, Daniele B, Webber AL, Ebbinghaus SW, Ma J, Siegel AB, Cheng AL, Kudo M; KEYNOTE-224 investigators. Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): a non-randomised, open-label phase 2 trial. Lancet Oncol. 2018 Jul;19(7):940-952. doi: 10.1016/S1470-2045(18)30351-6. Epub 2018 Jun 3.

Reference Type: RESULT

PMID: 29875066 (View on PubMed)

Wang H, Zhang X, Zhu K, Jiang S, Liu T, Feng R, Dou X, Xu L, He J, Shi F, Yue J. Efficacy and safety of radiotherapy to delay second-line systemic therapy in patients with oligoprogressive hepatocellular carcinoma: study protocol of a multicentre, single-arm, phase II trial. Ther Adv Med Oncol. 2025 Apr 23;17:17588359251334538. doi: 10.1177/17588359251334538. eCollection 2025.

Reference Type: DERIVED

PMID: 40297623 (View on PubMed)

Other Identifiers

SDZLEC2023-389-02

Identifier Type: -

Identifier Source: org_study_id