HCC - Hepatocellular CarcinomaPhase 2NCT06870942
Efficacy and Safety of Radiotherapy in Oligoprogressive HCC Following First-line PD-1 Therapy
A Phase 2 study testing Maintenance first-line treatment plus radiation therapy in people with HCC - Hepatocellular Carcinoma and Radiotherapy, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, Radiotherapy
- What is being tested?
- Maintenance first-line treatment plus radiation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2022to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hepatocellular carcinoma (HCC) based on either histopathologic or cytologic findings or a diagnosis of cirrhosis and HCC with classical imaging characteristics;
- HCC patients with oligoprogression after first-line PD-1 therapy ;
- Stable Disease for at least 3 months after first-line PD-1 therapy ;
- Oligoprogressive disease in 5 or fewer lesions and 3 or fewer organs
- Tumor staged as BCLC stage C
- ECOG performance status: 0-1.
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- Life expectancy >=6 months.
- No history of irradiation.
- aged 18 to 75 years old are eligible.
- Patients must be able to understand and willing to sign a written informed consent document.
- Female patients within childbearing age or male patients whose sexual partners are women within childbearing age need to take effective contraceptive measures throughout the treatment period and 6 months after the treatment.
Who cannot join
- Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma;
- History of hepatic encephalopathy or liver transplantation;
- Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage. Only a small amount of pleural effusion, ascites and pericardial effusion without symptoms could be included;
- Untreated hepatitis infection: HBV DNA>2000IU/mlor104 copy/ml, HCV RNA> 103copy/ml, both HbsAg and anti-HCV body are positive;
- Evidence with active central nervous system (CNS) metastases. Patients can be included if the CNS metastasis can be treated and the neurological symptoms can be restored to a level of <=1 degree of CTCAE (except for residual signs or symptoms associated with CNS treatment) for at least 2 weeks before the enrollment. In addition, patients must have not be treated with a corticosteroid, or just be treated with a stable dose of <= 10 mg prednisone/day (or equivalent dose) or with a dose reduced to 10 mg prednisone/day;
- In the past six months, there was a history of gastrointestinal perforation and/or fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive intestinal resection (partial or extensive intestinal resection with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea;
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- History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity;
- Evidence of active pulmonary tuberculosis (TB). Patients diagnosed with active tuberculosis infection within 1 year should be excluded even if they have been treated;
- Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
- Severe infections are in active stage or under clinical control. Severe infections occurred within 4 weeks before the first treatment, including but not limited to hospitalization due to infection, bacteremia or complications of severe pneumonia;
- Patients with active, known or suspected autoimmune diseases. Patients with the following conditions can be selected: vitiligo, type I diabetes, residual thyroid dysfunction caused by autoimmune thyroiditis that just need hormone replacement therapy, or diseases that will not relapse without external stimulating factors;
- Inoculation of any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within past 4 weeks;
- Large surgical (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures have been performed in the past four weeks;
- Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary tumors may lead to higher medical risks and/or uncertainty in survival assessment;
- Some acute or chronic diseases, psychiatric disorders or abnormal laboratory test values that may lead to the result: increased risk of participating in the study or drug administration, or interfering with the interpretation of research results, and according to the judgement of the researchers, patients are classified as not eligible to participate in the study;
- Other malignant tumors were diagnosed within 5 years before the first administration, excluding cured cutaneous basal cell carcinoma, cured squamous cell carcinoma and/or cured cancer in situ. If other malignant tumors or hepatocellular carcinomas are diagnosed more than five years before administration, pathological or cytological diagnosis should be taken from recurrent and metastasis sites;
- Pregnancy and breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Shu-jung Hsu, +8613585805072, 21111210002@m.fudan.edu.cn
Shi-suo Du
About this study
Official title: Efficacy and Safety of Radiotherapy in Oligoprogressive HCC Following First-line PD-1 Therapy: A Phase II Clinical Study
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
- HCC - Hepatocellular Carcinoma, Radiotherapy
- Being tested
- Maintenance first-line treatment plus radiation therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenance first-line treatment plus radiation therapyDrug
Maintenance first-line treatment plus radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Maintenance first-line treatment plus radiation therapy | Experimental | Not described Receives: Drug: Maintenance first-line treatment plus radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 6 months
Secondary outcomes (3)
Overall survival
Measured: 12 months
Objective response rate
Measured: 6 months
Disease control rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start28 Jul 2022
- Primary completion30 Nov 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870942
- Sponsor's protocol ID
- B2022-323R
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared with other researchers in order to protect patients' privacy.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Radiotherapy in Oligoprogressive HCC Following First-line PD-1 Therapy: A Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06870942
- Acronym / sponsor ID
- B2022-323R
- Conditions
- HCC - Hepatocellular Carcinoma, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance first-line treatment plus radiation therapy | Experimental | Drug: Maintenance first-line treatment plus radiation therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of hepatocellular carcinoma (HCC) based on either histopathologic or cytologic findings or a diagnosis of cirrhosis and HCC with classical imaging characteristics;
- HCC patients with oligoprogression after first-line PD-1 therapy ;
- Stable Disease for at least 3 months after first-line PD-1 therapy ;
- Oligoprogressive disease in 5 or fewer lesions and 3 or fewer organs
- Tumor staged as BCLC stage C
Key exclusion criteria (17 listed)
- Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma;
- History of hepatic encephalopathy or liver transplantation;
- Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage. Only a small amount of pleural effusion, ascites and pericardial effusion without symptoms could be included;
- Untreated hepatitis infection: HBV DNA>2000IU/mlor104 copy/ml, HCV RNA> 103copy/ml, both HbsAg and anti-HCV body are positive;
- Evidence with active central nervous system (CNS) metastases. Patients can be included if the CNS metastasis can be treated and the neurological symptoms can be restored to a level of <=1 degree of CTCAE (except for residual signs or symptoms associated with CNS treatment) for at least 2 weeks before the enrollment. In addition, patients must have not be treated with a corticosteroid, or just be treated with a stable dose of <= 10 mg prednisone/day (or equivalent dose) or with a dose reduced to 10 mg prednisone/day;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maintenance first-line treatment plus radiation therapyMaintenance first-line treatment plus radiation therapy | Drug | Maintenance first-line treatment plus radiation therapy |
Primary outcome
Progression-free survival
Time frame: 6 months
3 secondary outcomes
Overall survival
Time frame: 12 months
Objective response rate
Time frame: 6 months
Disease control rate
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No. The IPD will not be shared with other researchers in order to protect patients' privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maintenance first-line treatment plus radiation therapy in people with HCC - Hepatocellular Carcinoma and Radiotherapy, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shu-jung Hsu (+8613585805072, 21111210002@m.fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.