AdebrelimabPhase 2NCT06405061
Evaluation of Effectiveness and Safety of HAIC in Combination With Adebrelimab and Bevacizumab for Potentially Resectable Hepatocellular Carcinoma
A Phase 2 study testing Adebrelimab in people with Adebrelimab and Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 4 sites in China.
Trial summary
Primary liver cancer mainly consists of three different pathologic types: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and hybrid HCC-ICC, of which HCC accounts for 90%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adebrelimab, Hepatocellular Carcinoma
- What is being tested?
- Adebrelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesChina
- Study dates
- 1 May 2024to 1 Aug 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- patients voluntarily enrolled in the study and signed an informed consent form.
- 18-75 years old, both male and female.
- patients with HCC diagnosed histologically, cytologically, or clinically.
- CNLC-Ib to IIIaHCC (IIIa is limited to combined portal vein branch thrombosis Ching's staging grade I-III) of the Guidelines for the Management of Primary Liver Cancer (2022 edition).
- not have received any prior local and systemic therapy for HCC.
- at least one measurable lesion (the measurable lesion is ≥10 mm in long diameter or ≥15 mm in short diameter of enlarged lymph node on spiral CT scan according to RECISTv1.1).
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- Child-Pugh score ≤7.
- ECOG score:0~1.
- Expected survival ≥12 weeks.
- Vital organs function in accordance with the following requirements (within 7 days prior to initiation of study treatment).
- Routine blood tests: (except hemoglobin, which has not been transfused, granulocyte colony-stimulating factor [G-CSF], or corrected with medication within 14 days prior to screening): absolute neutrophil count ≥ 1.5 x 10^9/L; platelets ≥ 75 x 10^9/L; hemoglobin ≥ 90 g/L.
- Biochemical tests: (no albumin transfusion within 14 days prior to screening): serum albumin ≥29g/L; serum total bilirubin ≤1.5×upper limit of normal range (ULN); alanine aminotransferase (ALT), aspartate aminotransferase acid enzyme (AKP) ≤5×ULN; serum creatinine (Cr) ≤1.5ULN or Cr clearance >50mL/min.
- International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeding the range of normal control ≤ 6 seconds.
- Urine protein <2+ (if urine protein ≥2+, 24-hour (h) urine protein quantification can be performed, and 24-h urine protein quantification <1.0 g can be enrolled).
- 11. If the patient has active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid (DNA) must be <500 IU/mL (or <2500 copies/mL if only copies/mL are available at the study center), and has received at least 14 days of anti-HBV treatment prior to the initiation of study treatment (based on the standard of care in the local area, e.g., entecavir) and is willing to be enrolled at the time of study treatment. Patients who are hepatitis C virus (HCV) ribonucleic acid (RNA)-positive must be receiving antiviral therapy according to standard local treatment guidelines and have liver function within CTCAE grade 1 elevation.
- 12. Patients must agree to use contraception for at least 120 days from the date of informed consent until the last dose of study drug. Must have had a negative serum HCG test within 7 days prior to starting study treatment; must not be breastfeeding.
Who cannot join
- Known hepatobiliary ductal cell carcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrous platysmal cell carcinoma; active malignant tumors other than HCC within 5 years or at the same time. Cured limited tumors, such as basal cell carcinoma of the skin, squamous carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc. can be enrolled.
- Patients with combined portal vein branch thrombosis of grade IV or above in Cheng's staging.
- Patients who are going to undergo or have previously undergone organ or allogeneic bone marrow transplantation.
- Patients with clinically symptomatic moderate or severe ascites that requires therapeutic puncture or drainage or Child-Pugh score >2 (except those with only a small amount of ascites on imaging but not accompanied by clinical symptoms); uncontrolled or moderate amount or more of pleural effusion or pericardial effusion.
- Esophageal varices or fundal bleeding due to portal hypertension within the past 6 months; Presence of severe (G3) varices detected by endoscopy 3 months prior to initial dosing; Evidence of portal hypertension (including imaging findings of spleen more than 10 cm in length and platelets less than 100) and high risk of bleeding as assessed by the investigator.
- Arteriovenous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other history of severe thromboembolism. Implantable IV port or catheter derived thrombosis, or superficial vein thrombosis, except for thrombus stabilization after routine anticoagulation therapy.
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- Known hereditary or acquired bleeding (e.g., coagulation disorders) or thrombotic tendencies, such as in patients with hemophilia; Currently using or have recently (within 10 days prior to initiation of study treatment) used for therapeutic purposes full-dose oral or injectable anticoagulant or thrombolytic medications (prophylactic use of low-dose aspirin, low molecule heparin is permitted).
- current or recent (within 10 days prior to start of study treatment) treatment with aspirin (>325 mg/day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel and cilostazol.
- Thrombotic or embolic events, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., within 6 months prior to the start of study treatment.
- Uncontrolled cardiac clinical symptoms or diseases, such as: (1) Class II or higher cardiac insufficiency according to the New York Heart Association (NYHA) criteria (see Annex 5) or cardiac ultrasound: LVEF (left ventricular ejection fraction) < 50%; (2) unstable angina pectoris; (3) myocardial infarction within 1 year prior to the start of the study; (4) clinically significant supraventricular or ventricular arrhythmia requiring a cardiovascular or cardioembolic intervention; and (5) clinically significant supraventricular or ventricular arrhythmia requiring a cardiovascular or cardiac intervention; (6) cardiac disease or disease of the heart. or ventricular arrhythmia requiring treatment or intervention; (5) QTc>450ms (men); QTc>470ms (women) (QTc intervals were calculated using the Fridericia formula; if the QTc was abnormal, three consecutive tests were performed at 2-minute intervals, and the average value was taken).
- have hypertension that is not well controlled by antihypertensive medication (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) (based on the average of ≥2 BP readings), allowing the achievement of the above parameters through the use of antihypertensive therapy; have had a previous hypertensive crisis or hypertensive encephalopathy.
- significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to the start of study treatment; and
- severe, unhealed or gaping wounds and active ulcers or untreated fractures.
- major surgical treatment (other than diagnostic) within 4 weeks prior to the start of study treatment or anticipated need for major surgical treatment during the study period.
- previous intestinal obstruction and/or previous clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to initiation of study treatment, including incomplete obstruction related to a pre-existing condition or requiring routine parenteral hydration, parenteral nutrition, or tube feeding/tube feeding.
- Patients may be enrolled in the study if at the time of initial diagnosis patients with incomplete obstruction/obstruction syndrome/signs/symptoms of intestinal obstruction receive definitive (surgical) treatment to abate symptoms.
- evidence of an intra-abdominal pneumoperitoneum that cannot be explained by puncture or recent surgery.
- previous or current central nervous system metastases.
- Metastatic disease involving major airways or blood vessels (e.g., complete occlusion of the portal trunk or vena cava due to tumor invasion, which refers to the confluence of the splenic vein and the superior mesenteric vein, and the division of the hepatic portal vein into right and left branches) or a centrally located large mediastinal tumor mass (<30 mm from the crista longitudinalis).
- those with a history of hepatic encephalopathy.
- current concomitant interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring hormonal therapy, or other conditions that may interfere with the determination and management of immune-related pulmonary toxicity such as pulmonary fibrosis, organic pneumonia (e.g., occlusive bronchiectasis), pneumoconiosis, drug-associated pneumonia, idiopathic pneumonia, or active pneumonia as seen on a screening chest computed tomography (CT) picture Evidence or severely impaired lung function in subjects with a history of radiation pneumonitis in the permitted radiation field; active tuberculosis.
- presence of active autoimmune disease or history of autoimmune disease with potential for relapse (including, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects who can be controlled by hormone replacement therapy only are eligible for enrollment]); subjects with skin conditions that do not require systemic treatment such as vitiligopsoriasis, alopecia areata, controlled type I diabetes mellitus treated with insulin or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be included; asthmatics requiring medical intervention with bronchodilators may not be included.
- Immunosuppressive or systemic hormone therapy for immunosuppression within 14 days prior to initiation of study treatment (dose >10 mg/day prednisone or other equipotent hormone).
- Use of strong CYP3A4/CYP2C19 inducers including rifampicin (and its analogs) and oncolytic or strong CYP3A4/CYP2C19 inhibitors within 14 days prior to initiation of study treatment.
- severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; therapeutic antibiotics given orally or intravenously within 2 weeks prior to initiation of study treatment (patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection or exacerbation of COPD are eligible for study participation).
- Patients with congenital or acquired immune deficiency (e.g., HIV-infected patients).
- Combined hepatitis B and hepatitis C co-infection.
- Use of immunosuppressive drugs within 4 weeks prior to the first dose; and
- Received live attenuated vaccine within 4 weeks prior to the first dose or plan to receive live attenuated vaccine during the study.
- Received a traditional Chinese medicine with an antitumor indication or a drug with immunomodulatory effects within 2 weeks prior to the first dose of study drug.
- previous treatment with other anti-PD-1 antibodies or other immunotherapy targeting PD-1/PD-L1.
- palliative radiotherapy to non-target lesions for symptom control is permitted and must have been completed at least 2 weeks prior to the initiation of study treatment use, with no recovery from radiotherapy-induced adverse events to ≤ CTCAE grade 1.
- have received other experimental drug therapy within 28 days prior to initiation of study treatment.
- In the judgment of the investigator, the patient has other factors that may affect the results of the study or cause this study to be forced to be terminated in midstream, such as alcoholism, drug abuse, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors that would affect the patient's safety.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
Third Central Hospital of Tianjin
Tianjin, Tianjin Municipality
Tianjin First Central Hospital
Tianjin, Tianjin Municipality
About this study
Official title: A Prospective, Single-arm, Multicenter Phase II Clinical Study of Hepatic Arterial Perfusion Chemotherapy (FOLFOX) in Combination With Adebrelimab and Bevacizumab for Potentially Resectable Hepatocellular Carcinoma
Primary liver cancer mainly consists of three different pathologic types: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and hybrid HCC-ICC, of which HCC accounts for 90%. According to GLOBOCAN 2018 data, liver cancer is the sixth most prevalent tumor in the world, with about 841,100 new liver cancer cases and 781,600 deaths per year globally, which is the second leading cause of tumor deaths in men worldwide. China is a high incidence area of liver cancer, accounting for about 50% of the global incidence and deaths.
The treatment of HCC varies according to disease stage, which is based on the BCLC classification system, Child-Pugh liver function rating, and extent of disease. Approximately 30% of HCC cases are diagnosed in the early stages (i.e., BCLC stage 0 or A), and the main treatment options include surgical resection, ablation techniques, and liver transplantation. However, the 5-year recurrence rate remains as high as 70%. The recommended treatment for intermediate stage HCC (i.e., BCLC stage B) is hepatic artery intervention, i.e., transarterial chemoembolization (TACE), but the scope of applicability is limited due to concomitant disease and liver impairment factors, some patients do not derive a survival benefit from it, and patients ultimately progress after treatment and are no longer suitable for further TACE.
Read more
In recent years, the multi-drug combination therapy of systemic drugs combined with local therapy has also been gradually adopted, and studies have reported the feasibility of target drugs combined with ICI, TACE or HAIC for the treatment of unresectable hepatocellular carcinoma. The therapeutic aim of Adebrelimab (SHR-1316) is to inhibit tumor growth by specifically blocking the binding of PD-1 to PD-L1 and terminating the immunosuppressive signals generated by this receptor on T cells, so that T cells can re-recognize tumor cells and produce killing effects on them.
This study proposes an evaluation to explore the efficacy and safety of irinotecan liposome-based hepatic arterial perfusion chemotherapy (FOLFIRI) in combination with adebrelimab and bevacizumab for the treatment of potentially resectable hepatocellular carcinoma.
- Conditions
- Adebrelimab, Hepatocellular Carcinoma
- Being tested
- Adebrelimab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Also called Bevacizumab, HAIC
Adebrelimab: 1200 mg, IV, q3w
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Adebrelimab: 1200 mg, IV, q3w Bevacizumab: 7.5 mg/kg, IV, q3w HAIC: (FOLFOX regimen:oxaliplatin 65 mg/m2, folinic acid 200 mg/m2, 5-Fu 200 mg/m2 push, followed by continuous infusion for 24h 1200 mg/m25-Fu), Q3W) every 3 weeks until 6 treatments have been completed or HAIC treatment is terminated when patients with fewer than 6 treatments develop intolerable adverse effects Receives: Drug: Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate per RECIST 1.1
Defined as proportion of patients who have a best response of CR or PR
Measured: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year
Secondary outcomes (6)
Major Pathological response
the percentage of tumor cells before and after treatment was compared according to biopsy specimens before neoadjuvant therapy and pathological specimens after surgery; the percentage of tumor cells was evaluated on resected tumor slides. MPR was defined as ≤ 10% tumor cells.
Measured: After surgical excision with follow up of an average of 1 year
Disease Control Rate
Defined as proportion of patients who have CR or PR or SD
Measured: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year
R0 resection rate
Patients who underwent radical resection as a percentage of the total number of patients who underwent surgical resection
Measured: After surgical excision with follow up of an average of 1 year
Pathological complete response
Disappearance of tumor cells from resected specimen
Measured: After surgical excision with follow up of an average of 1 year
Event Free Survival
From date of surgery until the date of recurrence detection.
Measured: From treatment initiation to progressive disease, discontinuation of the treatment for any reason, or death due to any cause, assessed up to 1 year
Overall survival
Defined as the time from enrollment to death from any cause
Measured: From treatment initiation until death due to any cause, assessed up to 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 May 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Why it stopped: Mid-term data analysis for the project has been completed; enrollment is now suspended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdebrelimabStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405061
- Sponsor's protocol ID
- OBU-HCC-II-001
- Status last verified
- May 2025
- First submitted
- 25 Apr 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter Phase II Clinical Study of Hepatic Arterial Perfusion Chemotherapy (FOLFOX) in Combination With Adebrelimab and Bevacizumab for Potentially Resectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06405061
- Acronym / sponsor ID
- OBU-HCC-II-001
- Conditions
- Adebrelimab, Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Mid-term data analysis for the project has been completed; enrollment is now suspended.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 8 May 2024 (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.
Primary liver cancer mainly consists of three different pathologic types: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and hybrid HCC-ICC, of which HCC accounts for 90%. According to GLOBOCAN 2018 data, liver cancer is the sixth most prevalent tumor in the world, with about 841,100 new liver cancer cases and 781,600 deaths per year globally, which is the second leading cause of tumor deaths in men worldwide. China is a high incidence area of liver cancer, accounting for about 50% of the global incidence and deaths.
The treatment of HCC varies according to disease stage, which is based on the BCLC classification system, Child-Pugh liver function rating, and extent of disease. Approximately 30% of HCC cases are diagnosed in the early stages (i.e., BCLC stage 0 or A), and the main treatment options include surgical resection, ablation techniques, and liver transplantation. However, the 5-year recurrence rate remains as high as 70%. The recommended treatment for intermediate stage HCC (i.e., BCLC stage B) is hepatic artery intervention, i.e., transarterial chemoembolization (TACE), but the scope of applicability is limited due to concomitant disease and liver impairment factors, some patients do not derive a survival benefit from it, and patients ultimately progress after treatment and are no longer suitable for further TACE.
In recent years, the multi-drug combination therapy of systemic drugs combined with local therapy has also been gradually adopted, and studies have reported the feasibility of target drugs combined with ICI, TACE or HAIC for the treatment of unresectable hepatocellular carcinoma. The therapeutic aim of Adebrelimab (SHR-1316) is to inhibit tumor growth by specifically blocking the binding of PD-1 to PD-L1 and terminating the immunosuppressive signals generated by this receptor on T cells, so that T cells can re-recognize tumor cells and produce killing effects on them.
This study proposes an evaluation to explore the efficacy and safety of irinotecan liposome-based hepatic arterial perfusion chemotherapy (FOLFIRI) in combination with adebrelimab and bevacizumab for the treatment of potentially resectable hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: AdebrelimabAdebrelimab: 1200 mg, IV, q3w Bevacizumab: 7.5 mg/kg, IV, q3w HAIC: (FOLFOX regimen:oxaliplatin 65 mg/m2, folinic acid 200 mg/m2, 5-Fu 200 mg/m2 push, followed by continuous infusion for 24h 1200 mg/m25-Fu), Q3W) every 3 weeks until 6 treatments have been completed or HAIC treatment is terminated when patients with fewer than 6 treatments develop intolerable adverse effects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- patients voluntarily enrolled in the study and signed an informed consent form.
- 18-75 years old, both male and female.
- patients with HCC diagnosed histologically, cytologically, or clinically.
- CNLC-Ib to IIIaHCC (IIIa is limited to combined portal vein branch thrombosis Ching's staging grade I-III) of the Guidelines for the Management of Primary Liver Cancer (2022 edition).
- not have received any prior local and systemic therapy for HCC.
Key exclusion criteria (34 listed)
- Known hepatobiliary ductal cell carcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrous platysmal cell carcinoma; active malignant tumors other than HCC within 5 years or at the same time. Cured limited tumors, such as basal cell carcinoma of the skin, squamous carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc. can be enrolled.
- Patients with combined portal vein branch thrombosis of grade IV or above in Cheng's staging.
- Patients who are going to undergo or have previously undergone organ or allogeneic bone marrow transplantation.
- Patients with clinically symptomatic moderate or severe ascites that requires therapeutic puncture or drainage or Child-Pugh score >2 (except those with only a small amount of ascites on imaging but not accompanied by clinical symptoms); uncontrolled or moderate amount or more of pleural effusion or pericardial effusion.
- Esophageal varices or fundal bleeding due to portal hypertension within the past 6 months; Presence of severe (G3) varices detected by endoscopy 3 months prior to initial dosing; Evidence of portal hypertension (including imaging findings of spleen more than 10 cm in length and platelets less than 100) and high risk of bleeding as assessed by the investigator.
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 |
|---|---|---|
| AdebrelimabAlso: Bevacizumab, HAICAdebrelimab: 1200 mg, IV, q3w | Drug | Study arm |
Primary outcome
Objective Response Rate per RECIST 1.1
Time frame: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year
Defined as proportion of patients who have a best response of CR or PR
6 secondary outcomes
Major Pathological response
Time frame: After surgical excision with follow up of an average of 1 year
Disease Control Rate
Time frame: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year
R0 resection rate
Time frame: After surgical excision with follow up of an average of 1 year
Pathological complete response
Time frame: After surgical excision with follow up of an average of 1 year
Event Free Survival
Time frame: From treatment initiation to progressive disease, discontinuation of the treatment for any reason, or death due to any cause, assessed up to 1 year
Overall survival
Time frame: From treatment initiation until death due to any cause, assessed up to 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No. Study protocol
Related trials for Adebrelimab
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage
Not yet recruitingPhase 2
Neoadjuvant SHR-A1811 ± Adebrelimab in GC/GEJ
Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma
Not yet recruitingPhase 2
Exploratory Study of Short-Course Radiotherapy Followed by Adebrelimab Combined With Chemotherapy for Organ Preservation in Locally Advanced Rectal Cancer
Locally Advanced Resectable Rectal Cancer
Not yet recruitingPhase 3
A Study of TACE in Combination With SHR-8068, Adebrelimab, and Bevacizumab Versus TACE in Participants With Incurable Hepatocellular Carcinoma
Hepatocellular Carcinoma
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 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 Adebrelimab in people with Adebrelimab and Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 4 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 16 inclusion and 34 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: paused, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate per RECIST 1.1 (time frame: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year). 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 29 May 2026.