NCT06841172 Continuation of First-line Therapy With Radiotherapy Versus Early Switch to Second-line Therapy in Oligoprogressive HCC
| NCT ID | NCT06841172 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shandong Cancer Hospital and Institute |
| Condition | OligoProgressive Metastatic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2025-07-21 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 132 participants in total. It began in 2025-07-21 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This multicenter, prospective, randomized, controlled, open-label, two-arm Phase III clinical trial is designed to evaluate whether adding radiotherapy to oligoprogressive lesions while continuing first-line systemic therapy at the time of oligoprogression can effectively prolong progression-free survival compared to early switching to second-line systemic therapy in oligoprogressive hepatocellular carcinoma.
Eligibility Criteria
Inclusion Criteria: * 1\. Histological or cytological confirmation of primary hepatocellular carcinoma (HCC), or diagnosis based on the Clinical Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 edition) issued by the National Health Commission of the People's Republic of China. * 2\. BCLC stage C at the time of first-line systemic treatment. * 3\. Oligoprogression must be confirmed by imaging or histopathology during first-line systemic therapy (FLST). The number of oligoprogressive lesions is limited to 1-5, involving no more than 1-3 organs or systems. These lesions may represent either new metastatic sites or progression of pre-existing lesions. In addition, they must fit one of the two classifications defined in the ESTRO-EORTC consensus on oligometastases: repeat oligoprogression or induced oligoprogression. Oligoprogression may occur within intrahepatic lesions. In the case of lymph node progression, each lymphatic drainage region is considered a separate lesion. For example, the para-aortic lymph nodes (number 16a and number 16b) are each counted as separate lymph node regions. * 4\. Patients must have experienced oligoprogression while receiving their current FLST and must not have previously received any other FLST that resulted in disease progression. Additionally, the current FLST must have maintained disease stability (SD) for at least three months prior to the occurrence of oligoprogression. Furthermore, the expected survival time must be ≥6 months. * 5\. Oligoprogressive lesions must be eligible for radiotherapy and should have at least one measurable lesion that meets RECIST v1.1 criteria; Bone metastases without soft tissue formation are eligible but are considered non-measurable lesions; Bone metastases with soft tissue formation that meet RECIST v1.1 measurable criteria are considered measurable lesions. * 6\. Liver function must be assessed as Child-Pugh score ≤7 points. * 7\. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1. * 8\. Participants must be able to understand and voluntarily sign a written informed consent prior to the initiation of any study-specific procedures and must agree to comply with the treatment and follow-up requirements of the study. * 9\. Male or female patients between 18 and 75 years of age. * 10\. Availability of tumor and blood samples for biomarker assessment. Exclusion Criteria: * 1\. Patients who received FLST as adjuvant treatment after curative surgery for HCC. * 2\. Tumor progression occurring within 3 months after initiation of FLST. * 3\. Patients with combined hepatocellular-cholangiocarcinoma (cHCC-CC) * 4\. History of grade ≥3 serious adverse events due to FLST. * 5\. Presence of brain, peritoneal or omental metastases with bleeding after FLST. * 6\. Previous radiation therapy to the site of the oligoprogressive lesion. * 7\. Active untreated hepatitis B, defined as HBsAg positive with HBV DNA levels above the upper limit of normal in the participating center's laboratory. * 8\. Oligoprogressive lesions not amenable to radiotherapy. * 9\. Alpha-fetoprotein (AFP) level ≥10,000 ng/mL at the time of oligoprogression. * 10\. Diagnosis of malignancy other than liver cancer within 3 years prior to enrollment (excluding curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or carcinoma in situ). * 11\. Currently participating in any interventional clinical research treatment or having received any other investigational drug or investigational device therapy within the last 4 weeks prior to enrollment. * 12\. Presence of autoimmune disease or other conditions requiring long-term steroid use. * 13\. Severe impairment of the heart, lungs, kidneys, or other vital organs, active infections (other than viral hepatitis), or other serious comorbidities that render the patient unable to tolerate treatment. * 14\. known or suspected allergy to any study drug or to any drug related to this study. * 15\. History of organ transplantation * 16\. Pregnant or breastfeeding women * 17\. Any other factor that the investigator believes may affect the enrollment of patients or the evaluation of study results.
Contact & Investigator
Jinbo Yue, Doctor
PRINCIPAL INVESTIGATOR
Shandong Cancer Hospital and Institute
Frequently Asked Questions
Who can join the NCT06841172 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying OligoProgressive Metastatic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06841172 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 132 participants.
Is NCT06841172 currently recruiting?
Yes, NCT06841172 is actively recruiting participants. Contact the research team at jbyue@sdfmu.edu.cn for enrollment information.
Where is the NCT06841172 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06841172 clinical trial?
NCT06841172 is sponsored by Shandong Cancer Hospital and Institute. The principal investigator is Jinbo Yue, Doctor at Shandong Cancer Hospital and Institute. The trial plans to enroll 132 participants.