Hepatocellular CarcinomaPhase 2NCT07317414
β-alanine in the Treatment of Advanced Hepatocellular Carcinoma
A Phase 2 study testing Atezolizumab combined with bevacizumab combined with β- alanine and Atezolizumab combined with bevacizumab in people with Hepatocellular Carcinoma, run by Peking Union Medical College Hospital at 3 sites in China.
Trial summary
This study is a prospective, randomized controlled study on nutritional support and metabolic regulation. It assesses the safety, compliance, and improvement of metabolic/physical-related indicators when using β-alanine within the specified dose range as dietary supplementation, in addition to the standard first-line… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Atezolizumab combined with bevacizumab combined with β- alanine and Atezolizumab combined with bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 3 sitesChina
- Study dates
- 24 Dec 2025to 5 Dec 2030
- 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
- The subjects voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance, cooperated with the follow-up, and were over 18 years old at the time of signing the informed consent form, with no restrictions on gender.
- Patients diagnosed by imaging and histological examinations as having unresectable, recurrent, locally advanced or metastatic liver cell carcinoma, or meeting the clinical diagnostic criteria for liver cell carcinoma as defined by the American Association for the Study of Liver Diseases (AASLD); BCLC stage C, with no distant metastasis or lymph node metastasis, or BCLC stage B, who are not eligible for therapeutic surgery
- With measurable lesions (according to the RECIST 1.1 standard, non-lymph node lesions have a CT scan long diameter of ≥ 10 mm, and lymph node lesions have a CT scan short diameter of ≥ 15 mm)
- At least 4 weeks prior to the baseline assessment, radical surgery/local treatment was not suitable, or disease progression occurred thereafter. The treatments included lesion resection, ablation, transcatheter arterial chemoembolization, hepatic artery infusion chemotherapy, radiotherapy, etc. All acute toxic effects during local treatment must be ≤ CTCAE5.0 grade 1.
- For patients undergoing non-surgical sterilization or those of childbearing age, a medically approved contraceptive method must be used during the study treatment period and within 3 months after the end of the study treatment; for non-surgical sterilization patients of childbearing age, the serum or urine HCG test must be negative within 7 days before the study enrollment; and they must be non-lactating; For non-surgical sterilization or male patients of childbearing age, they must agree to use a medically approved contraceptive method with their spouses during the study treatment period and within 3 months after the end of the study treatment.
- The functions of the important organs should meet the following requirements: i. Blood test: Absolute neutrophil count 1.5×109/L, platelet count ≥ 50×109/L, hemoglobin ≥ 90g/L; ii. Liver function: Serum total bilirubin ≤ 3×upper limit of normal; Alanine aminotransferase and aspartate aminotransferase ≤ 5×ULN; Serum albumin ≥ 28 g/L; Alkaline phosphatase ≤ 5×ULN; After conventional liver-protective treatment meets the above standards and can be stable for at least 1 week as evaluated by the investigator, it can be enrolled; iii. Kidney function: Serum creatinine ≤ 1.5×ULN, or creatinine clearance rate ≥ 50 mL/min (using the standard Cockcroft-Gault formula), urine test shows urine protein < 2+; For patients whose urine test at baseline shows urine protein ≥ 2+, 24-hour urine collection should be conducted and the 24-hour urine protein quantification < 1g.
- Coagulation function: The international normalized ratio and activated partial thromboplastin time should be ≤ 1.5 × ULN; if the subject is undergoing anticoagulation therapy, as long as the PT and INR are within the range prescribed by the anticoagulant drug, it is acceptable.
Who cannot join
- Previously diagnosed with fibrotic plate-like hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components through histological/cytological methods;
- Who have previously received local or systemic anti-tumor treatment, or undergone liver transplantation
- Received radiotherapy within 3 weeks prior to the first administration of the drug
- If there has been a history of esophageal or gastric fundus variceal bleeding caused by portal hypertension within 6 months prior to the first administration of the drug, participation in this study is not permitted. If the gastroscopy indicates severe (G3) varices, participation is not allowed.
- Tumor volume > 50% of liver volume; portal vein tumor thrombus (Vp4, tumor thrombus involving the main portal vein, or the tumor mainly affecting the primary branch of the portal vein on the opposite side of the liver lobe, or the primary branches of the bilateral portal veins) and inferior vena cava tumor thrombus. Note: If the tumor thrombus does not completely block the portal vein, and there is still blood flow visible on imaging, the patient can be included in the study.
- Regardless of the severity, for any patient with any signs or history of bleeding predisposition, or for any patient who experienced any bleeding or bleeding-related event of grade ≥ CTCAE 3 within 4 weeks prior to the first administration of the medication
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- Severe bleeding tendency or coagulation dysfunction, or currently undergoing thrombolytic therapy; Arterial and venous thromboembolic events occurred within 6 months before the first administration. Implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis, is excluded in cases where thrombosis stabilizes after conventional anticoagulant therapy
- Uncontrollable hypertension, with systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg after the best medical treatment, history of hypertensive crisis or hypertensive encephalopathy
- Previous history of myocarditis, cardiomyopathy, or malignant arrhythmia; symptomatic congestive heart failure or left ventricular ejection fraction value < 50% on echocardiography. Symptomatic or poorly controlled arrhythmia, including atrial fibrillation or atrial flutter with a ventricular rate greater than 100 beats per minute.
- Patients who have objective evidence of past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function
- History of gastrointestinal perforation and/or fistula, intestinal obstruction, extensive bowel resection, Crohn's disease, ulcerative colitis or long-term chronic diarrhea within 6 months prior to the first administration of the drug
- Active pulmonary tuberculosis: Those who are currently undergoing anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to the first administration.
- The subjects must not have any active autoimmune diseases or a history of autoimmune diseases; the subjects must not have congenital or acquired immune deficiencies, such as HIV-infected individuals, or must not have received live vaccines within 4 weeks prior to the administration of the study medication or during the study period.
- The subjects are undergoing treatment with immunosuppressants, either systemic or local absorbable hormones, with the aim of achieving immunosuppression (dose > 10mg/day of prednisone or other equivalent efficacy hormones), and they have continued to use these medications within the 2 weeks prior to enrollment.
- The subjects had active infections or experienced unexplained fever above 38.5 degrees Celsius during the screening period or before the first administration (in cases where the fever was caused by the tumor, the subjects could be included in the study).
- The researchers believe that these cases should be excluded from this study. For instance, based on the researchers' assessment, the participants have other factors that might cause the study to be prematurely terminated. Such factors include, for example, the need for combined treatment for other serious diseases (including mental illnesses), severe gastric fundal esophageal varices, severe abnormal laboratory test results, and factors related to family or society that could affect the safety of the participants or the collection of data and samples.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Haitao Zhao, Dr., 86-19201026001, jypeking@163.com
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
Lin Lu, +86-19201016001, jypeking@163.com
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Lin Lu, +86-19201016001, jypkeing@163.com
About this study
Official title: A Randomized Clinical Trial Exploring β-alanine as an Adjunct to First-line Immunotherapy in Advanced Hepatocellular Carcinoma
This study is a prospective, randomized controlled study on nutritional support and metabolic regulation. It assesses the safety, compliance, and improvement of metabolic/physical-related indicators when using β-alanine within the specified dose range as dietary supplementation, in addition to the standard first-line treatment. The anti-tumor efficacy (ORR, PFS, OS) is the exploratory endpoint.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Atezolizumab combined with bevacizumab combined with β- alanine, Atezolizumab combined with bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atezolizumab combined with bevacizumab combined with β- alanineDrug
Atezolizumab (Tecentriq®) + Bevacizumab (Avastin®)+β- alanine
Atezolizumab combined with bevacizumabDrug
Atezolizumab (Tecentriq®) + Bevacizumab (Avastin®)
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab combined with bevacizumab combined with β- alanine | Experimental | Atezolizumab combined with bevacizumab combined with β- alanine Receives: Drug: Atezolizumab combined with bevacizumab combined with β- alanine |
| Atezolizumab combined with bevacizumab | Active comparator | Atezolizumab combined with bevacizumab Receives: Drug: Atezolizumab combined with bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale score (range 0-52); higher scores indicate less fatigue (better outcome).
Measured: Within 7 days prior to Day 1 of each treatment cycle (each cycle is 21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start24 Dec 2025 (estimated)
- Primary completion5 Dec 2028 (estimated)
- Study completion5 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317414
- Sponsor's protocol ID
- BARO-HCC
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Taking into account the protection of patient information, the clinical data will not be made public.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Exploring β-alanine as an Adjunct to First-line Immunotherapy in Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07317414
- Acronym / sponsor ID
- BARO-HCC
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 24 Dec 2025 (estimated)
- Primary completion
- 5 Dec 2028 (estimated)
- Study completion
- 5 Dec 2030 (estimated)
- First posted
- 5 Jan 2026 (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.
This study is a prospective, randomized controlled study on nutritional support and metabolic regulation. It assesses the safety, compliance, and improvement of metabolic/physical-related indicators when using β-alanine within the specified dose range as dietary supplementation, in addition to the standard first-line treatment. The anti-tumor efficacy (ORR, PFS, OS) is the exploratory endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab combined with bevacizumab combined with β- alanine | Experimental | Drug: Atezolizumab combined with bevacizumab combined with β- alanineAtezolizumab combined with bevacizumab combined with β- alanine |
| Atezolizumab combined with bevacizumab | Active comparator | Drug: Atezolizumab combined with bevacizumabAtezolizumab combined with bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subjects voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance, cooperated with the follow-up, and were over 18 years old at the time of signing the informed consent form, with no restrictions on gender.
- Patients diagnosed by imaging and histological examinations as having unresectable, recurrent, locally advanced or metastatic liver cell carcinoma, or meeting the clinical diagnostic criteria for liver cell carcinoma as defined by the American Association for the Study of Liver Diseases (AASLD); BCLC stage C, with no distant metastasis or lymph node metastasis, or BCLC stage B, who are not eligible for therapeutic surgery
- With measurable lesions (according to the RECIST 1.1 standard, non-lymph node lesions have a CT scan long diameter of ≥ 10 mm, and lymph node lesions have a CT scan short diameter of ≥ 15 mm)
- At least 4 weeks prior to the baseline assessment, radical surgery/local treatment was not suitable, or disease progression occurred thereafter. The treatments included lesion resection, ablation, transcatheter arterial chemoembolization, hepatic artery infusion chemotherapy, radiotherapy, etc. All acute toxic effects during local treatment must be ≤ CTCAE5.0 grade 1.
- For patients undergoing non-surgical sterilization or those of childbearing age, a medically approved contraceptive method must be used during the study treatment period and within 3 months after the end of the study treatment; for non-surgical sterilization patients of childbearing age, the serum or urine HCG test must be negative within 7 days before the study enrollment; and they must be non-lactating; For non-surgical sterilization or male patients of childbearing age, they must agree to use a medically approved contraceptive method with their spouses during the study treatment period and within 3 months after the end of the study treatment.
Key exclusion criteria (16 listed)
- Previously diagnosed with fibrotic plate-like hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components through histological/cytological methods;
- Who have previously received local or systemic anti-tumor treatment, or undergone liver transplantation
- Received radiotherapy within 3 weeks prior to the first administration of the drug
- If there has been a history of esophageal or gastric fundus variceal bleeding caused by portal hypertension within 6 months prior to the first administration of the drug, participation in this study is not permitted. If the gastroscopy indicates severe (G3) varices, participation is not allowed.
- Tumor volume > 50% of liver volume; portal vein tumor thrombus (Vp4, tumor thrombus involving the main portal vein, or the tumor mainly affecting the primary branch of the portal vein on the opposite side of the liver lobe, or the primary branches of the bilateral portal veins) and inferior vena cava tumor thrombus. Note: If the tumor thrombus does not completely block the portal vein, and there is still blood flow visible on imaging, the patient can be included in the study.
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 |
|---|---|---|
| Atezolizumab combined with bevacizumab combined with β- alanineAtezolizumab (Tecentriq®) + Bevacizumab (Avastin®)+β- alanine | Drug | Atezolizumab combined with bevacizumab combined with β- alanine |
| Atezolizumab combined with bevacizumabAtezolizumab (Tecentriq®) + Bevacizumab (Avastin®) | Drug | Atezolizumab combined with bevacizumab |
Primary outcome
The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Time frame: Within 7 days prior to Day 1 of each treatment cycle (each cycle is 21 days).
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale score (range 0-52); higher scores indicate less fatigue (better outcome).
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 5 Jan 2026.
- Individual participant dataSharing planned: No. Taking into account the protection of patient information, the clinical data will not be made public.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab combined with bevacizumab combined with β- alanine and Atezolizumab combined with bevacizumab in people with Hepatocellular Carcinoma, run by Peking Union Medical College Hospital at 3 sites 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 7 inclusion and 16 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 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Haitao Zhao (+86-19201026001, jypeking@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (time frame: Within 7 days prior to Day 1 of each treatment cycle (each cycle is 21 days).). 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 5 Jan 2026.