Status:
NOT_YET_RECRUITING
Second-line Systemic Therapy Combined with SBRT for HCC with Oligoprogression After Standard First-line Systemic Treatment
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Oligoprogression
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Approximately 70% of hepatocellular carcinoma (HCC) patients are diagnosed at an advanced stage, with no opportunity for curative treatments. For these patients, systemic therapies are the main treatm...
Eligibility Criteria
Inclusion
- KPS (Karnofsky Performance Status) score ≥ 80;
- Pathologically, or clinically diagnosed hepatocellular carcinoma (HCC) based on the \" Chinese Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2024 Edition) \";
- Patients with oligoprogression after first-line standard systemic therapy (bevacizumab combined with atezolizumab/sintilimab or lenvatinib with or without PD-1 antibody).
- Definition of oligoprogression: 1-5 progressive lesions involving 1-3 organs/systems, including: (1)The maximum diameter of a target lesion, as assessed by RECIST 1.1 criteria, increases by more than 20% compared to baseline, with an absolute increase of \>5 mm; (2) The maximum diameter of a target lesion increases by more than 20% compared to baseline on two consecutive evaluations (at least 2 months apart), regardless of whether the absolute increase is \>5 mm; (3) The appearance of a new intrahepatic lesion ≥1 cm with typical imaging characteristics of HCC; 4) The appearance of any new extrahepatic lesion or bone metastasis, regardless of size; 5) Any new FDG-avid lesion confirmed by PET/CT, or an increase in SUVmax of more than 30% with an absolute increase of \>0.8 SUV; 6) In the case of lymph node metastasis, each lymphatic drainage area is counted as one organ.
- All oligoprogressive lesions are deemed suitable for radiotherapy, with a maximum diameter of any single oligoprogressive lesion not exceeding 5 cm, and at least one measurable lesion (according to RECIST v1.1 criteria); bone metastases without soft tissue formation are eligible but considered non-measurable lesions; if bone metastases have soft tissue formation and meet measurable criteria, they are considered measurable lesions;
- Child-Pugh score for liver function ≤ 7;
- Estimated life expectancy greater than 3 months;
- Function of essential organs meets the following criteria: white blood cells ≥ 3.0 × 10\^9/L, neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 50.0 × 10\^9/L, hemoglobin ≥ 90 g/L; serum albumin ≥ 2.8 g/dL; total bilirubin ≤ 1.5 × ULN, ALT/AST/ALP ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance \> 60 mL/min; no severe organic disease;
- Participants must have the ability to understand and voluntarily sign a written informed consent form. Consent must be obtained before any specific study procedures begin, and the participant must agree to follow the medication and post-operative follow-up requirements outlined in the study design.
Exclusion
- Received first-line treatment other than bevacizumab combined with atezolizumab/sintilimab or lenvatinib with or without PD-1 antibody;
- Tumor progression within 3 months after first-line standard systemic therapy;
- Experienced ≥ Grade 3 severe adverse reactions after first-line standard therapy;
- Brain metastasis with hemorrhage at baseline or after first-line systemic therapy;
- Previous radiotherapy to the site of the oligoprogressive lesion;
- Active bleeding (e.g., hematemesis, hemoptysis) within 2 months before enrollment;
- Received any other antitumor drug therapy or local treatment within 3 months before enrollment;
- Severe impairment of the heart, lungs, kidneys, or other vital organs, active infections (other than viral hepatitis), or other severe comorbidities that make the patient unable to tolerate treatment;
- History of other malignancies, except for non-melanoma skin cancer, carcinoma in situ of the cervix, or early-stage prostate cancer that has been cured;
- Presence of autoimmune diseases or other conditions requiring long-term use of steroids;
- Known or suspected allergy to the study drugs or any drugs related to this trial;
- History of organ transplantation;
- Pregnant or breastfeeding women;
- Other factors that may affect the patient\'s enrollment and assessment results;
- Refusal to follow the follow-up requirements set by this study protocol or refusal to sign the informed consent form.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06592612
Start Date
October 1 2024
End Date
October 31 2026
Last Update
September 19 2024
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