Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06870942

Efficacy and Safety of Radiotherapy in Oligoprogressive HCC Following First-line PD-1 Therapy

Led by Shanghai Zhongshan Hospital · Updated on 2025-03-11

35

Participants Needed

1

Research Sites

174 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Immune checkpoint inhibitors (ICIs) have significantly improved the survival outcomes of HCC patients. However, a considerable proportion of patients eventually experience disease progression due to the development of resistance. Among these, oligoprogression is a common manifestation, occurring in 10-55.3% of advanced cancer patients. Local therapy, especially radiotherapy (RT), has been increasingly considered in the setting of oligoprogression to overcome ICIs resistance and delay the need to change systemic therapy. Therefore, this study aimed to explore the efficacy and safety of RT in oligoprogressive HCC following first-line PD-1 therapy.

CONDITIONS

Official Title

Efficacy and Safety of Radiotherapy in Oligoprogressive HCC Following First-line PD-1 Therapy

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of hepatocellular carcinoma (HCC) based on histopathologic or cytologic findings, or diagnosis of cirrhosis and HCC with classical imaging characteristics
  • Oligoprogression after first-line PD-1 therapy
  • Stable disease for at least 3 months after first-line PD-1 therapy
  • Oligoprogressive disease involving 5 or fewer lesions and 3 or fewer organs
  • Tumor staged as BCLC stage C
  • ECOG performance status of 0-1
  • Life expectancy of at least 6 months
  • No prior history of irradiation
  • Age between 18 and 75 years old
  • Ability to understand and willingness to sign written informed consent
  • Use of effective contraceptive measures during treatment and for 6 months afterwards for females of childbearing potential and male patients with partners of childbearing potential
Not Eligible

You will not qualify if you...

  • Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma
  • History of hepatic encephalopathy or liver transplantation
  • Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage (asymptomatic small amounts allowed)
  • Untreated hepatitis infection with HBV DNA >2000 IU/ml or 10^4 copy/ml, or HCV RNA >10^3 copy/ml, or positive for both HbsAg and anti-HCV antibody
  • Active central nervous system metastases unless treated with neurological symptoms controlled to CTCAE grade ≤1 for at least 2 weeks
  • Use of corticosteroids above 10 mg prednisone/day or equivalent within 2 weeks before enrollment
  • History in past 6 months of gastrointestinal perforation, fistula, intestinal obstruction requiring parenteral nutrition, inflammatory bowel disease, extensive intestinal resection with chronic diarrhea, Crohn's disease, ulcerative colitis, or chronic diarrhea
  • History of symptomatic interstitial lung disease or other lung conditions complicating drug-related toxicity
  • Active pulmonary tuberculosis infection within past year
  • Positive test for HIV or AIDS
  • Severe infections active or within 4 weeks before treatment including hospitalization for infection or severe pneumonia complications
  • Active, known, or suspected autoimmune diseases except certain stable conditions
  • Anti-infective vaccine received within past 4 weeks
  • Major surgery or unhealed wounds, ulcers, or fractures within past 4 weeks
  • Uncontrolled metabolic disorders or other serious non-malignant diseases or secondary tumors increasing medical risks
  • Acute or chronic diseases, psychiatric disorders, or abnormal labs increasing study risk or interfering with results
  • Diagnosis of other malignant tumors within 5 years before first administration (except certain cured skin cancers)
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

S

Shu-jung Hsu

CONTACT

S

Shi-suo Du

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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