NCT03236649|TerminatedPhase 3

Study Stopped

Because the clinical development plan has been changed.

The Phase III Study of Icaritin Versus Sorafenib in PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects

Comparison of Efficacy and Safety of Icaritin Versus Sorafenib in First-line Treatment of PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects: a Multicenter, Randomized, Opened Phase III Clinical Trial

Beijing Shenogen Biomedical Co., Ltd ClinicalTrials.gov

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1 other identifier

SNG1705ICR-2

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredAug 2017

StartedSep 2017

CompletionFeb 2022

Brief Summary

The primary efficacy index of this study is to compare the OS of the two groups.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Sep 2017

Typical duration for phase_3

Geographic Reach

1 country

26 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.4 years study duration

First Submitted

Initial submission to the registry

July 26, 2017

Completed

7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed

2 months until next milestone

Study Start

First participant enrolled

September 20, 2017

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2022

Completed

Last Updated

February 8, 2023

Status Verified

January 1, 2021

Enrollment Period

4.4 years

First QC Date

July 26, 2017

Last Update Submit

February 7, 2023

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

Overall survival (OS)
OS is defined as the time from randomization to died from any cause. For the subjects who failed to visit, deletion is performed on the final date of knowing the survival of the subjects, for subjects who still survive, deletion is performed on the data expiration date.
1-2 years

Secondary Outcomes (6)

Progression-free survival (PFS)
1-2 years
Time to progress（TTP）
1-2 years
Overall response rate (ORR)
1-2 years
Overall disease control rate (DCR)
1-2 years
Assessment on Quality of life 1
1-2 years
+1 more secondary outcomes

Other Outcomes (2)

Biomarker analysis of proteome level (Immunohistochemical method)
1-2 years
Genome level (DNA, mRNA, miRNA) biomarker analysis
1-2 years

Study Arms (2)

Icaritin

EXPERIMENTAL

600mg/time, 6 capsules/time(6×100mg/capsule), 2 times/day(30 minutes after breakfast, lunch and dinner), take orally, continuous administration until reach the standard of termination.

Drug: Icaritin

Sorafenib Tosylate Tablets

ACTIVE COMPARATOR

400mg/time, 2 tablets/time(2×200mg/tablet), 2times/day(Fasting), take orally, continuous administration until reach the standard of termination.

Drug: Sorafenib Tosylate Tablets

Interventions

IcaritinDRUG

600mg/time, 6 capsules/time(6×100mg/capsule), 2 times/day(30 minutes after breakfast, lunch and dinner), take orally, continuous administration until reach the standard of termination.

Icaritin

Sorafenib Tosylate TabletsDRUG

400mg/time, 2 tablets/time(2×200mg/tablet), 2times/day(Fasting), take orally, continuous administration until reach the standard of termination.

Sorafenib Tosylate Tablets

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients who meet any of the following criteria are not allowed to enter the test:
Aged between 18 and 75 years old, no gender restriction;
According to "Primary Liver Cancer Diagnosis and Treatment Standard." (2011 Edition) issued by the National Health and Family Planning Commission, advanced or metastatic hepatocellular carcinoma patients who diagnosed by pathology /cytology fail to undergo liver surgery and/or other local treatment (ablation or hepatic artery intervention), or have recurrence and progression after surgery and/or other local treatment;
Not previously accepted first-line system therapy (systemic chemotherapy, molecular targeting, immunotherapy and research medication, etc.) for advanced or metastatic HCC, including but not limited to systematic chemotherapy with oxaliplatin, sorafenib, PD-1/PD-L1 antibody and Icaritin, etc.;
The central laboratory must receive specimen of tumor tissue (wax block or white slice) at first, and detect the PD-L1of tumor tissues by immunohistochemistry, only positive expression of PD-L1 in immune cells can be enrolled;
According to the evaluation criteria of solid tumor reaction (RECIST 1.1), it has at least one measurable target lesion (Non-lymph node lesions with the longest diameter larger than 10mm, lymph node lesions with the short diameter larger than 15mm); the lesions previously received local treatment such as ablation or hepatic artery interventional therapy should be detected by computed tomography (CT) / magnetic resonance imaging (MRI) and according to RECIST1.1, It's sure that disease progression has occurred and the longest diameter is more than 1.0cm,it can be used as a measurable target lesions;
Liver surgery was performed more than 3 months ago, ablation or interventional treatment of hepatic artery was performed more than 4 weeks ago, and the adverse reactions returned to normal; After surgery or other local treatment, if patients have gone beyond the norm for systemic adjuvant chemotherapy or sorafenib, it will need more than 6 months after the chemotherapy or sorafenib, and disease progression and / or metastasis have occurred;
The Child-Pugh score of liver function is grade A or better grade B (score≤7);
The ECOG score of physical condition is 0-1;
Expected survival time≥12 weeks;
weeks before the first medication of the trial, there is no use of modern Chinese medicine preparation with liver cancer indication, including Delisheng injection, Kanglaite injection/soft capsule, Aidi injection or Cotside injection, elemene injection/oral liquid, Huaier granule, cinobufotalin and GanFuLe capsule / tablet and so on.
The function of the main organs is basically normal and meets the following requirements:
① Marrow: Absolute neutrophil count≥1.5×109/L, platelet≥80×109/L, hemoglobin≥90g/L;
② Liver: Total bilirubin≤1.5 times of the upper limit of normal(ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤5 × ULN; albumin≥29g/L;
③ Kidney: Serum creatinine≤ 1.5 x ULN, or creatinine clearance rate≥ 50ml/min;
+4 more criteria

You may not qualify if:

Patients who meet any of the following criteria are not allowed to enter the test:
Imaging examination shows that HCC liver tumors are huge (≥60% of the liver volume), or cancer embolus of portal trunk (occupying ≥50% of the vascular diameter), or cancer embolus invading mesenteric vein or inferior vena cava;
Middle or higher ascites which is clinically significant, it requires therapeutic abdominal paracentesis /drainage, or the Child-Pugh score \> 2;
Local anticancer therapy (including surgery, ablation, hepatic arterial chemotherapy, embolization or radiotherapy) or major surgery was performed 28 days prior to randomization;
Hepatocholangiocarcinoma and fibrolamellar cell carcinoma; In the past or at the same time, there were other cancers whose primary site or histology are entirely different from hepatocellular carcinoma, except cervical carcinoma in situ, previously treated basal cell carcinoma and superficial bladder tumor (Ta, Tis, T1); Patients with other malignancies who have been cured for \>5 years prior to enrollment may be admitted to the group;
Pregnant or lactating women;
Patients who have high blood pressure and failed to receive good control with antihypertensive drugs (systolic blood pressure \>140mmHg, diastolic pressure \>100mmHg); Patients suffer from CTCAE classification type II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia; and/or New York Heart Association(NYHA) grade III to IV cardiac dysfunction.
Allograft transplants including liver transplantation were performed previously, or a liver transplant was planned during the trial;
Hepatic encephalopathy and / or hepatic nephropathy occurred within 6 months;
Patient with active hepatitis C, that is, anti -HCV positive or HCV-RNA positive and abnormal liver function;
Human immunodeficiency virus (HIV) tests are positive or severe infection requiring systemic treatment with antibiotics;
Inability to swallow, chronic diarrhea or intestinal obstruction that significantly affecting medication intake and absorption;
Having a history of digestive tract bleeding within 6 months, or with a clear gastrointestinal bleeding tendency, including local active ulcerative lesions, positive fecal occult blood;
The patient has or is suspected to have known active autoimmune disease;
If a central nervous system metastasis is known and a metastasis of the central nervous system is suspected, the cranial MRI examination should be performed to exclude it;
+4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Beijing Shenogen Biomedical Co., Ltdlead
Cancer Institute and Hospital, Chinese Academy of Medical Sciencescollaborator
Eastern Theater General Hospital,QinHuai District Medical Areacollaborator
Peking University Cancer Hospital & Institutecollaborator
Chinese PLA General Hospitalcollaborator
Beijing Hospitalcollaborator
General Hospital of Chinese Armed Police Forcescollaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciencescollaborator
Jinan Central Hospitalcollaborator
Linyi Cancer Hospitalcollaborator
The First Affiliated Hospital of Anhui Medical Universitycollaborator
Anhui Provincial Hospitalcollaborator
The First Affiliated Hospital with Nanjing Medical Universitycollaborator
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, Chinacollaborator
Nanfang Hospital, Southern Medical Universitycollaborator
First People's Hospital of Foshancollaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical Universitycollaborator
Tianjin Medical University Cancer Institute and Hospitalcollaborator
Hebei Medical University Fourth Hospitalcollaborator
Hunan Cancer Hospitalcollaborator
The First Hospital of Jilin Universitycollaborator
307 Hospital of PLAcollaborator
Fudan Universitycollaborator
Henan Cancer Hospitalcollaborator
Jilin Provincial Tumor Hospitalcollaborator
First Affiliated Hospital of Harbin Medical Universitycollaborator
The First Affiliated Hospital of Bengbu Medical Universitycollaborator
The First Affiliated Hospital of Soochow Universitycollaborator
Tongji Hospitalcollaborator
Beijing YouAn Hospitalcollaborator

Study Sites (26)

First Affiliated Hospital Bengbu Medical College

Bengbu, Anhui, China

Location

Anhui Provincial Hospital

Hefei, Anhui, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Beijing Hospital