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Clinical Trials in China / NCT04344158
Active, not recruiting Phase 3

A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

NCT04344158 · tracked via the Priya Life Science China tracker
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase
Phase 3
Started
2020-08-11
Last updated
2025-02-20

Condition(s) studied

Advanced Hepatocellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

AK105 InjectionAnlotinib Hydrochloride CapsulesSorafenib Tosylate Tablets

AK105 Injection: AK105 200mg intravenously (IV) on day 1 of each 21-day cycle.

Anlotinib Hydrochloride Capsules: Anlotinib capsules 10mg given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Sorafenib Tosylate Tablets: Sorafenib Tosylate Tablets 400mg given orally, twice daily in 21-day cycle.

Study summary

This is a randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus Sorafenib. Patients are treated with AK105 injection combined with Anlotinib Hydrochloride Capsules or Sorafenib, with 2:1 random ratio. Every 21 days is a treatment cycle.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 1\. 18-75 years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months. 2\. Histopathology or cytology confirmed as HCC. 3. Has not received any systematic treatment for HCC. 4. Stage B or C in the Barcelona Clinic Liver Cancer (BCLC) classification, and is not suitable for surgery or local treatment, or progress after surgery or local treatment. 5\. Child-Pugh liver function classification : A or B (≤7 points). 6. Central nervous system metastasis has no clinical symptoms or is stable at least 4 weeks after treatment. 7\. Quantification of HBV DNA \<500IU/ml or 2500 Copys/ml, and anti-HBV therapy should be given for at least 2 weeks before the first administration; Quantification of HCV RNA is positive must complete antiviral therapy at least 1 month before the first administration. 8\. Patients who progress after local treatment should be at least 4 weeks after the end of local treatment. 9\. Radiotherapy for bone metastases accompanied by clinical symptoms must be completed at least 2 weeks before the first administration. 10\. Has at least one measurable lesion. 11. Adequate organ function. 12. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization. 13.Understood and signed an informed consent form. Exclusion Criteria: * 1\. Histopathology or cytology confirmed as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, hepatobiliary cell carcinoma, mixed liver cancer, etc. 2\. Has used anti-angiogenic drugs such as anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, bevacizumab, or related immunotherapy drugs for PD-1, PD-L1, etc. 3\. Has received systemic treatment such as chemotherapy and biological therapy. 4. Has a history of hepatic encephalopathy. 5. According to imaging examination, the portal vein has invasion of cancer embolus, inferior vena cava or heart involvement. 6\. Hepatitis B with hepatitis C or hepatitis D infection. 7. Has received or planned to receive organ transplantation. 8. Has other malignant tumors within 5 years. 9. Has multiple factors affecting oral medication. 10. Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 11\. Has any bleeding or bleeding events ≥grade 3 in the first 4 weeks before the first administration. 12\. Has unhealed wounds, fractures, active gastric and duodenal ulcers, positive continuous fecal occult blood, ulcerative colitis in the first 4 weeks before the first administration. 13\. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1. 14\. Has received surgery, or unhealed wounds within 4 weeks before the first administration. 15\. Has drug abuse history that unable to abstain from or mental disorders. 16. Has any serious and / or uncontrolled disease. 17. Has received vaccination or attenuated vaccine within 4 weeks prior to the first administration. 18\. Has received anti-tumor Traditional Chinese Medicine within 2 weeks before the first administration. 19\. Severe hypersensitivity after administration of other monoclonal antibodies. 20\. Has any active autoimmune disease or history of autoimmune disease. 21.Immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose \&gt; 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration. 22.Has participated in other anticancer drug clinical trials within 4 weeks. 23.Portal hypertension with high risk of hemorrhage, or have red sign confirmed by gastroscopy. 24.According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Primary outcome measure(s)

Trial sites (81)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui
Anhui Provincial Hospital Hefei Anhui
The First Affiliated Hospital of Anhui Medical University Hefei Anhui
Anhui Provincial Cancer Hospital Hefei Anhui
Beijing Ditan Hospital.Capital Medical University Beijing Beijing Municipality
Beijing YouAn Hospital.Capital Medical University Beijing Beijing Municipality
Peking Union Medical College Hospital Beijing Beijing Municipality
Chinese Pla General Hospital Beijing Beijing Municipality
Beijing Tsinghua Changgung Hospital Beijing Beijing Municipality
Beijing Luhe Hospital.Capital Medical University Beijing Beijing Municipality
The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality
Chongqing University Three Gorges Hospital Chongqing Chongqing Municipality
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
Fujian Provincial Cancer Hospital Fuzhou Fujian
The First Affiliated Hospital of Xiamen University Xiamen Fujian
Zhongshan Hospital Xiamen University Xiamen Fujian
The first hospital of Lanzhou University Lanzhou Gansu
Lanzhou University Second Hospital Lanzhou Gansu
Gansu Wuwei Tumour Hospital Wuwei Gansu
Guangdong Provincial People's Hospital Guangzhou Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong
The First Affiliated Hospital,Sun Yat-sen University Guangzhou Guangdong
Guangxi Medical University Affiliated Tumor Hospital Nanning Guangxi
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
The Second Nanning People's Hospital Nanning Guangxi
Guizhou Provincial People's Hospital Guiyang Guizhou
Cancer Hospital of Guizhou Medical University Guiyang Guizhou
Affiliated Hospital of Zunyi Medical University Zunyi Guizhou
Hainan General Hospital Haikou Hainan
The Second Affiliated Hospital of Hainan Medical Universit Haikou Hainan
The Third Hospital of Hebei Medical University Shijiazhuang Hebei
First Hospital Of Qinhuangdao Qinhuangdao Hebie
Affiliated Hospital of Chengde Medical University Chengde Heibei
Affiliated Tumor Hospital of Harbin Medical University Harbin Heilongjiang
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan
Nanyang First People's Hospita Nanyang Henan
Sanmenxia Central Hospital Sanmenxia Henan
Xinxiang central hospital Xinxiang Henan
Henan Cancer Hospital Zhengzhou Henan
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

+ 41 more sites — see the full list on the official registry below.

More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04344158 on ClinicalTrials.gov ↗ ← All trials in China