Immunotherapy combo aims to shrink advanced liver tumors
NCT ID NCT04605796
First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This phase 2 trial investigates whether combining toripalimab (an immunotherapy) with bevacizumab (a drug that cuts off tumor blood supply) can safely shrink advanced liver cancer when used as the first treatment. About 50 to 60 adults with intermediate or late-stage liver cancer that cannot be treated with surgery will receive the drug combination every three weeks. The study primarily tracks side effects and how many patients' tumors shrink or disappear.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- toripalimab and bevacizumab
- What this could lead to
- If successful, this combination could offer a new first-line treatment option for people with advanced liver cancer, potentially shrinking tumors and delaying disease progression.
- What could go wrong
- This is an early-phase, single-arm study with a small number of participants, so results may not apply broadly. Side effects from immunotherapy and anti-angiogenic drugs can be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
54 people
The number who actually took part.
- Started
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Apr 2020
- Finished
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May 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
"The patients meeting all the following inclusion criteria can be enrolled in this study: 1. Age of 18-70 years (inclusive), male or female. 2. HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2017 Edition). 3. Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage). In case of stage B, the patient must be unsuitable for surgery and/or local therapy, or have progressive disease after surgery and/or local therapy, or refuse surgery and/or local therapy (special instruction and signature required). 4. No previous use of any systemic therapy or HCC. 5. Having ≥ 1 measurable lesion in accordance with RECISTv1.1. 6. Grade A Child-Pugh hepatic function, with no history of hepatic encephalopathy. 7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-1. 8. Expected survival ≥12 weeks. 9. Adequate hematologic and end-organ function.. 10. In case of HBsAg (+) and/or HBcAb (+), HBV DNA is required to be \< 500 IU/mL, and it is required to continue the effective anti-HBV therapy that has been adopted in the full course, or start to use Entecavir or tenofovir in the full course during the study. HBV/HCV co-infected patients will be excluded. Patients with a history of HCV infection but with negative HCV RNA PCR results can be considered uninfected with HCV. 11. Female patients of childbearing potential must receive serum pregnancy test within 7 days before enrollment, have negative result, and agree to use reliable and effective contraceptive methods during the trial and within 60 days after the last dose of study drug. The male patients whose partners are women of childbearing potential must agree to use reliable and effective contraceptive methods during the trial and within 60 days after the last dose of study drug. 12. Being voluntary to participate in the study, sufficiently informed consent and signature of written informed consent form, with good compliance. Patients can not be enrolled in the study if any one of the following criteria is fulfilled: 1. Known cholangiocellular carcinoma (ICC) or mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma and hepatic fibrolamellar carcinoma. 2. Malignant tumor except HCC in the past 5 years: however, localized tumor cured in the study is excluded, including cervical carcinoma in situ, skin basal cell carcinoma and carcinoma in situ of prostate. 3. Hepatic surgery and/or local therapy or treatment with investigational product for HCC within 4 weeks prior to enrollment; palliative therapy for bone metastatic lesion within 2 weeks prior to enrollment. Toxicity reaction induced by previous therapy (except alopecia) not recovered to ≤ grade 1 (NCI-CTCAE v5.0). Chinese medicine preparation with anti-liver cancer effect within 2 weeks prior to enrollment. 4. Uncontrolled pericardial effusion, uncontrolled pleural effusion or clinically obvious moderate peritoneal effusion at screening, 5. History of gastrointestinal hemorrhage within 6 months prior to enrollment; the patients with portal hypertension need to receive gastroscopy to exclude the patients with "red sign", if they are considered by investigators to have high risk for hemorrhage . The patient needs to be excluded if there is a history of "red sign" in gastroscopy. 6. Having ≥ grade 3 (NCI-CTCAE v5.0) gastrointestinal or non-gastrointestinal fistula at present. 7. Patients with cancer thrombus in the main trunk of portal vein (Vp4), or cancer thrombus in inferior vena cava should be excluded. However, the patients with cancer thrombus in the main trunk of portal vein but unobstructed branch of contralateral portal vein are allowed to be enrolled. 8. Previous history of serious cardiovascular and cerebrovascular diseases: 9. Having major bleeding and coagulation disorders or other obvious evidence on hemorrhagic tendency: 10. Medium to large surgical treatment within 4 weeks prior to enrollment, however, not including diagnostic biopsy. 11. Central nervous system metastasis. 12. Serious, uncured wound, active ulcer or untreated bone fracture. 13. Vaccination of live vaccine within 30 days prior to enrollment. 14. Active autoimmune diseases requiring systemic treatment (i.e., immunomodulatory drug, corticosteroid or immunosuppressant) in the past 2 years; however, replacement therapy (e.g., thyroxine, insulin or physiological corticosteroid replacement therapy for renal or pituitary insufficiency) will not be considered as systemic therapy and is allowed to be used, and enrollment is allowed. 15. History of clear interstitial lung disease or non-infectious pneumonia, unless induced by local radiotherapy; history of active tuberculosis. 16. Any serious acute and chronic infection requiring systemic antibacterial, antifungal or antiviral therapy at screening, not including viral hepatitis. 17. Known history of human immunodeficiency virus (HIV) infection. 18. Previously receiving allogeneic stem cell or solid organ transplantation. 20\. Known history of serious allergy to any monoclonal antibody, anti-angiogenesis targeted drug. "
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Beijing Cancer hospital
Beijing, China
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Other studies related to the condition(s) this trial covers.
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