Study to Investigate the Efficacy and Safety of CS1003 in Combination with Lenvatinib Compared to Placebo in Combination with Lenvatinib in Subjects with advanced liver cancer

Phase 1

• Conditions: unresectable advanced hepatocellular carcinoma; MedDRA version: 21.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003337-41-PL
• Lead Sponsor: CStone Pharmaceuticals (Suzhou) Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-17
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 534

Inclusion Criteria

1.Age =18 years on the day of signing informed consent (For Taiwan, the lower limit of age is 20 years).
2.Subjects with unresectable advanced HCC that is not eligible for
surgery and/or locoregional therapy (Stage B or C based on Barcelona
Clinic Liver Cancer [BCLC] staging system) and meets either one of the following criteria: 1) histologically or cytologically confirmed diagnosis of HCC, 2) clinically confirmed diagnosis of HCC according to American Association for the study of Liver Diseases (AASLD) criteria.
3. With at least one measurable lesion can be assessed.
4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
5. Life expectancy = 3 months.
6. Child-Pugh A.
7. No prior systemic treatment for advanced HCC.
8. Subjects with hepatitis B virus (HBV) infection are willing to continue receiving antiviral treatment while on study.
9. Subjects have adequate organ and marrow function.
10. Female subjects with childbearing potential must have negative serum pregnancy test result at screening. Female subjects with childbearing potential, and male subjects and their female partners with childbearing potential must agree to use a contraceptive method(s) detailed in the protocol from the day of signing informed consent form (ICF), during the study and till at least 6 months after the last dose.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 265

Exclusion Criteria

1.Fibrolamellar HCC, sarcomatoid HCC, cholangiocellular carcinoma or mixed cholangiocarcinoma and HCC.
2. A prior bleeding event due to esophageal or gastric varices within 6 months or other gastrointestinal bleeding events within 28 days prior to
screening. Untreated or incompletely treated esophageal or gastric varices that are considered by the investigator to be at high-risk for
bleeding (Note: Patients must undergo an esophagogastroduodenoscopy [EGD], and all size of varices [small to large] must be assessed and
treated per local standard of care prior to enrollment; patients who have undergone an EGD within 6 months prior to the initiation of study
treatment do not need to repeat the procedure). Active gastric or duodenal ulcer.
3. Malabsorption syndrome or inability to take oral medication due to
other causes.
4. HBV and HCV co-infection.
5. Surgery or locoregional therapy for palliative purpose (e.g., to treat
bone metastases or metastases causing nerve impingement) within 4
weeks prior to study treatment.
6. History of other malignancy(ies) in the past 5 years, except for
malignant disease treated with curative intent and without active
disease.
7. Known history of human immunodeficiency virus (HIV) infection or
acquired immunodeficiency syndrome (AIDS).
8. Current or prior use of systemic corticosteroid (> 10 mg/day
prednisone or equivalent) or other immunosuppressive medication
within 14 days prior to the first dose of study treatment.
9. History of bone marrow transplantation or organ transplantation.
10. History of anaphylaxis or hypersensitivity to any ingredient of the
investigational product.
11. Any contraindication of lenvatinib.
12.Known history of drug abuse that would interfere with cooperation with the requirements of the trial.
13. Pregnant or lactating female subjects.
14. History of psychiatric disease that would interfere with cooperation with the requirements of the trial; lack of or with restricted physical capability.
15. QTc interval > 470 msec (as calculated with Fridericia's formula) at
screening electrocardiogram (ECG);
16. Any condition that would in the investigator's judgment, prevent the subject from participating in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified