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Advanced Hepatocellular Carcinoma (HCC)Phase 3NCT04344158

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

A Phase 3 study testing AK105 Injection, Anlotinib Hydrochloride Capsules and Sorafenib Tosylate Tablets in people with Advanced Hepatocellular Carcinoma (HCC), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 81 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Hepatocellular Carcinoma (HCC)
What is being tested?
AK105 Injection, Anlotinib Hydrochloride Capsules and Sorafenib Tosylate Tablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
648 participants
Where
81 sitesChina
Study dates
11 Aug 2020to Dec 2026
Phase
Phase 3
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

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

81 sites in 1 country.

81 sites in 1 country

China81 sites

  • Baoji Central Hospital

    Baoji, Shaanxi, 721000

  • Beijing Ditan Hospital.Capital Medical University

    Beijing, Beijing Municipality, 100015

  • Beijing YouAn Hospital.Capital Medical University

    Beijing, Beijing Municipality, 100069

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Chinese Pla General Hospital

    Beijing, Beijing Municipality, 100853

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 102218

  • Beijing Luhe Hospital.Capital Medical University

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • Jilin Cancer Hospital

    Changchun, Jilin, 13000

  • The First Hospital Affiliated to Jilin Universit

    Changchun, Jilin, 130021

  • Jilin Guowen Hospital

    Changchun, Jilin, 130700

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • Hunan Cancar Hospital

    Changsha, Hunan, 410013

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410021

  • Hunan Cancer Hospital(Department II of Gastroenterology and Urology/Hepatobiliary Surgery)

    Changsha, Hunan, 410205

  • Affiliated Hospital of Chengde Medical University

    Chengde, Heibei, 67020

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610042

  • Affiliated Hospital of Chengdu University

    Chengdu, Sichuan, 610081

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404031

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, 350014

  • Gansu Provincial Hospital

    Gansu, Lanzhou, 730099

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510289

  • The First Affiliated Hospital，Sun Yat-sen University

    Guangzhou, Guangdong

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 550002

  • Cancer Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550081

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • The Second Affiliated Hospital of Hainan Medical Universit

    Haikou, Hainan, 570311

  • Shulan (Hangzhou) hospital

    Hangzhou, Zhejiang, 310015

  • Hanzhong Central Hospital

    Hanzhong, Shaanxi, 723000

  • Affiliated Tumor Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230031

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121012

  • The first hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • Liaocheng people's Hospital

    Liaocheng, Shandong, 252004

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637000

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210000

  • The Second Hospital of Nanjing

    Nanjing, Jiangsu, 210003

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210029

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530021

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • The Second Nanning People's Hospital

    Nanning, Guangxi, 530031

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226361

  • Nanyang First People's Hospita

    Nanyang, Henan, 473006

  • First Hospital Of Qinhuangdao

    Qinhuangdao, Hebie, 350014

  • Sanmenxia Central Hospital

    Sanmenxia, Henan, 472000

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital, Fuadn University

    Shanghai, Shanghai Municipality, 200032

  • The Third Affiliated Hospital of the Second Military Medical University of the Chinese people's Liberation Army

    Shanghai, Shanghai Municipality, 201800

  • The Sixth People's Hospital Of Shenyang

    Shenyang, Liaoning, 110006

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110042

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

  • Shanxi Provinaial Cancer Hospital

    Taiyuan, Shanxi, 030013

  • Tianjin Medical University Cancar institute & Hospital

    Tianjin, Tianjin Municipality, 300060

  • Tianjin Third Central Hospital

    Tianjin, Tianjin Municipality, 300170

  • Tianjin Second People's Hospital

    Tianjin, Tianjin Municipality, 300192

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang Uygur Autonomous Region, 830054

  • Yidu Central Hospital Of Weifang

    Weifang, Shandong, 262550

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Wenzhou People's Hospital

    Wenzhou, Zhejiang, 325041

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • Gansu Wuwei Tumour Hospital

    Wuwei, Gansu, 733000

  • Tangdu Hospital of the Fourth Military Medical University of the People's Liberation Army of China

    Xi’an, Shanxi, 710038

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • Shanxi Provincial Cancer Hospital

    Xi’an, Shanxi, 710061

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

  • Xinxiang central hospital

    Xinxiang, Henan, 453000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563099

Other trials in China

About this study

Official title: A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

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.

Being tested
AK105 Injection, Anlotinib Hydrochloride Capsules, Sorafenib Tosylate Tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK105 InjectionDrug

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

  • Anlotinib Hydrochloride CapsulesDrug

    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 TabletsDrug

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

Study groups in NCT04344158
Study groupRoleWhat they receive
AK105 combined with AnlotinibExperimentalAK105 200mg intravenously (IV) on day 1 of each 21-day cycle plus 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).
Receives: Drug: AK105 Injection; Drug: Anlotinib Hydrochloride Capsules
Sorafenib Tosylate TabletsActive comparatorSorafenib Tosylate Tablets 400mg given orally, twice daily in 21-day cycle.
Receives: Drug: Sorafenib Tosylate Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    OS defined as the time from the first dose to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

    Measured: Up to 96 weeks

Secondary outcomes (4)

  1. Progression-free survival (PFS)

    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

    Measured: Up to 96 weeks

  2. Overall response rate（ORR）

    Percentage of subjects achieving complete response (CR) and partial response (PR).

    Measured: Up to 96 weeks

  3. Disease control rate（DCR）

    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).

    Measured: Up to 96 weeks

  4. Duration of Response (DOR)

    DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

    Measured: Up to 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2020
  2. Study start11 Aug 2020
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
648 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04344158
Sponsor's protocol ID
ALTN-AK105-III-02
Status last verified
Nov 2024
First submitted
10 Apr 2020
Last updated
20 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou J, Bai L, Luo J, Bai Y, Pan Y, Yang X, Gao Y, Shi R, Zhang W, Zheng J, Hua X, Xu A, Hu S, Zhang F, Yang X, Da M, Wang R, Ma J, Jia W, Quan D, Peng C, Yang W, Yin G, Qi Y, Zhang G, Du X, Mao X, Meng Z, Jiao S, Fan J; APOLLO Study Group. Anlotinib plus penpulimab versus sorafenib in the first-line treatment of unresectable hepatocellular carcinoma (APOLLO): a randomised, controlled, phase 3 trial. Lancet Oncol. 2025 Jun;26(6):719-731. doi: 10.1016/S1470-2045(25)00190-1. Epub 2025 May 8.

    PubMed 40349716

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AK105 Injection, Anlotinib Hydrochloride Capsules and Sorafenib Tosylate Tablets in people with Advanced Hepatocellular Carcinoma (HCC), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 81 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 8 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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?

Overall survival (OS) (time frame: Up to 96 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04344158, which also lists 1 linked publication.

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 20 Feb 2025.

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