Cadonilimab in Combination With Ramucirumab for the Treatment of Advanced Hepatocellular Carcinoma That Has Failed at Systemic Therapy

Trial Title: Cadonilimab in Combination With Ramucirumab for the Treatment of Advanced Hepatocellular Carcinoma That Has Failed at Systemic Therapy

NCT ID: NCT05856864

Condition: Advanced Hepatocellular Carcinoma That Has Failed at Systemic Therapy

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Ramucirumab

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cadonilimab Injection
Description: Cadonilimab Injection, 10mg/kg, intravenous drip ,q2w,
Arm group label: Cadonilimab in Combination With Ramucirumab

Other name: AK104

Intervention type: Drug
Intervention name: Ramucirumab Injection
Description: Ramucirumab Injection，8mg/kg, intravenous drip ,q2w,
Arm group label: Cadonilimab in Combination With Ramucirumab

Summary: To evaluate the efficacy Cadonilimab in combination with Ramucirumab for the treatment of advanced Hepatocellular Carcinoma that has failed at systemic therapy

Detailed description: An open, single-arm, single-centre,Phase II clinical study evaluating Cadonilimab in combination with Ramucirumab for the treatment of advanced hepatocellular carcinoma that has failed at systemic therapy

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. written informed consent signed prior to enrolment. 2. age > 18 years, both sexes 3. patients with histologically or pathologically confirmed intermediate to advanced hepatocellular carcinoma. 4. Previously received systemic drug treatment for HCC, with disease progression or intolerable toxicity 5. Child-Pugh A or B7 6. with measurable lesions (≥10 mm long diameter on CT scan for non-lymph node lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to RECIST 1.1 criteria). 7. ECOG PS score: 0 to 1. 8. expected survival of >12 weeks. 9. function of vital organs in accordance with the following requirements (excluding the use of any blood components and cell growth factors within 14 days). 1) Blood count. Neutrophils ≥ 1.5 x 109/L Platelet count ≥ 60×109/L haemoglobin ≥ 90 g/L. 2) Liver and kidney function. Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula). total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN) Glutamic aminotransferase (AST) or glutamic aminotransferase (ALT) levels ≤ 10 times the upper limit of normal (ULN); urine protein < 2+; if urine protein ≥ 2+, 24-hour urine protein quantification must show ≤ 1 g of protein. 10. normal coagulation function, no active bleeding or thrombotic disease 1. International normalised ratio INR ≤ 1.5 x ULN. 2. partial thromboplastin time APTT ≤ 1.5 x ULN. 3. prothrombin time PT ≤ 1.5 x ULN. 11. Female patients who are non-surgically sterilised or of childbearing age are required to use a medically approved contraceptive (e.g. IUD, pill or condom) during and for 3 months after the end of the study treatment period; female patients of childbearing age who are non-surgically sterilised must have a negative serum or urine HCG test within 7 days prior to study entry; and must be non-lactating; male patients who are non-surgically sterilised or of childbearing age Patients, need to agree to use a medically approved form of contraception with their spouse during and for 3 months after the end of the study treatment period. 12. The subject is voluntarily enrolled in the study, is compliant and cooperates with safety and survival follow-up Exclusion Criteria: Patients with any of the following are not eligible for enrollment in this study. 1. Subjects with previous or concurrent other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix). 2. the subject has received previous immunotherapy other than anti-PD-1/PD-L1 monoclonal antibody; the subject is known to have a previous allergy to macromolecular protein agents, or is known to be allergic to the components of the drug applied. 3. The subject has any active autoimmune disease or history of autoimmune disease (e.g. the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, previous thyroid surgery cannot be included; the subject has vitiligo or has complete remission of asthma in childhood and in adulthood (subjects who do not require any intervention can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included). 4. subjects who are on immunosuppressive, or systemic, or absorbable topical hormone therapy for immunosuppressive purposes (doses >10 mg/day of prednisone or other isotonic hormones) and who continue to use them within 2 weeks prior to enrolment 5. have clinically symptomatic ascites or pleural effusion requiring therapeutic puncture or requiring frequent drainage of ascites (≥1 time/month) 6. subjects with clinically symptomatic cardiac conditions or diseases that are not well controlled, such as (1) NYHA class 2 or higher heart failure (2) unstable angina pectoris (3) previous myocardial infarction within 1 year (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention 7. subjects with active infection or unexplained fever >38.5 degrees during screening and prior to the first dose (subjects with fever arising from a tumour may be enrolled, as judged by the investigator) 8. patients with previous and current objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severely impaired lung function 9. subjects with congenital or acquired immune deficiency, e.g. HIV infection 10. subjects who have received a live vaccine less than 4 weeks prior to study drug administration or possibly during the study period 11. subjects with a known history of psychotropic substance abuse, alcoholism or drug use 12. patients who are unable to administer the drug orally 13. have received herbal or proprietary Chinese medicine with an anti-tumour indication within 2 weeks prior to the first dose . 14 Patients who, in the opinion of the investigator, should be excluded from the study, for example, subjects who, in the judgment of the investigator, have other factors that may force the study to be terminated, e.g., other serious illnesses (including psychiatric illnesses) requiring comorbid treatment, severe fundic esophageal varices, serious laboratory test abnormalities, accompanying family or social factors that would compromise the safety of the subject, or the collection of data and samples.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Tianjin Cancer Hospital Airport Hospital

Address:
City: Tianjin
Zip: 300308
Country: China

Status: Recruiting

Contact:
Last name: Huikai Li, MD

Phone: 18622228639
Email: tjchlhk@126.com

Contact backup:
Last name: Yang Liu, MD

Phone: 17694950696

Start date: June 1, 2024

Completion date: May 1, 2025

Lead sponsor:
Agency: Tianjin Medical University Cancer Institute and Hospital
Agency class: Other

Source: Tianjin Medical University Cancer Institute and Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05856864