Status:
UNKNOWN
Lenvatinib in Combination With Camrelizumab as First-Line Therapy in Patients With Advanced HCC
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a single arm, open-label, non-randomized and single-center phase I/II clinical study, to evaluate the the safety, tolerance and efficacy of Lenvatinib plus Camrelizumab as first-line therapy i...
Detailed Description
The purpose of this study is to evaluate the safety, tolerance and efficacy of Lenvatinib combined with Camrelizumab as first-line therapy for patients with advanced hepatocellular carcinoma.The targe...
Eligibility Criteria
Inclusion
- Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol;
- Males or females, age ≥ 18 years at the time of informed consent;
- Imaging (by AASLD or Standard for the diagnosis and treatment of primary liver cancer 2017 in China) or histopathologically or cytologically confirmed advanced HCC;
- BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy;
- No previous systematic treatment for HCC;
- Have at least one measurable lesion (in accordance with RECIST v1.1); the measurable lesion has a long diameter ≥ 10 mm or lymphadenopathy has a short diameter ≥ 15 mm in spiral CT scan;
- ECOG-PS score 0 or 1
- Child-Pugh Class: Grade A
- Life Expectancy of at least 3 months
- Subjects with HBV infection: HBV DNA\<2000 IU/ml or \<10\^4 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study, subjects with HCV-RNA(+) must receive antiviral therapy;
- Hematology and organ functions are sufficient based on the following laboratory results within 14 days prior to the treatment of this study:
- Whole blood cell examination (no blood transfusion within 14 days, no G-CSF use and no drugs use): WBC ≥ 3.0×10\^9/L, HB ≥ 85 g/L; Neutrophils ≥ 1.5×10\^9/L; PLT≥75×10\^9/L; Biochemical examination (no ALB infused within 14 days): ALB ≥ 29 g/L; ALP and ALT and AST \< 5×ULN; TBIL≤3×ULN; Adequate renal function: Cr≤1.5×ULN, or CCr\>50mL/min; Female: CrCl = ((140- year) x weight (kg) x 0.85)/72x Cr (mg/dL) Male: CrCl = ((140- year) x weight (kg) x 1.00)/72xCr (mg/dL)
- Agree to abstain from sex (avoid heterosexual intercourse) or use contraceptive methods with an annual contraceptive failure rate of less than 1% during treatment and for at least 6 months after the last administration.
Exclusion
- Hepatocellular carcinoma patients with any of the following:
- Suitable for radical surgery; without an assessment lesion after radical surgery; liver transplantation history or ready for liver transplantation;
- History of hepatic encephalopathy;
- Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma;
- Pregnant women (positive pregnancy test before taking medicine) or lactating women;
- Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug (or any excipient);
- Received any topical treatment within 4 weeks prior to the study, including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection;
- Previous or existing CTCAE 5.0 standard grade 3 or above gastrointestinal fistula or non-gastrointestinal fistula (such as skin);
- Factors to affect oral administration and absorption (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Ascites with clinical symptoms (i.e. ascites with Child-Pugh rating \> 2) or cancerous ascites require therapeutic abdominal puncture or drainage. Or uncontrolled malignant ascites (ascites that researchers believe diuretics or puncture cannot control);
- Major surgical operations (except biopsy) were performed within 4 weeks prior to the first study of drug therapy or the surgical incision was not completely healed; Minor surgery (i.e. simple resection, biopsy, etc.) was performed within 7 days before the first round of research intervention.
- Cardiovascular and cerebrovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, cerebrovascular accident or transient ischemic attack, congestive heart failure occurred within 6 months prior to admission (New York Heart Association Grade ≥2, see Appendix 4); Arrhythmia requiring antiarrhythmic drugs (except β receptor blocker or digoxin); Repeated ECG detection QTcF interval\>480 milliseconds (ms).
- Hepatic and renal insufficiency, such as jaundice, ascites, and/or bilirubin\>3×ULN, creatinine ratio\>3.5g/24h, or renal failure requiring blood or peritoneal dialysis, etc. And/or urine routine showed proteinuria ≥++or confirmed 24-hour proteinuria\>1.0g.
- Persistent\>2 grade (CTC-AE5.0) infection.
- History of thromboembolism (including stroke and/or transient ischemic attack) in the past 6 months.
- Hypertension (systolic blood pressure\>160mmHg, diastolic blood pressure\>100 mmHg) that not be well controlled through antihypertensive drug treatment.
- History of active autoimmune diseases or autoimmune diseases in the past two years.
- Known central nervous system metastasis and/or cancerous meningitis.
- Be ready for or previously received organ or allogenic bone marrow transplantation.
- Known history of active tuberculosis (Mycobacterium tuberculosis).
- History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage.
- History of human immunodeficiency virus (HIV)infection.
- Active hepatitis B virus or C virus infection and not receive regular treatment;
- Serious non-healing wound, ulcer or fracture.
- Drug abuse exists; or any medical, psychological or social condition that may affect research, unstable patient compliance or even endanger patient safety.
- Any\>1 grade (CTC-AE 5.0) unresolved toxicity due to previous treatment or operation, except for hair loss, anemia, and hypothyroidism.
- Previous and current evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia and severe impairment of lung function.
- Received a potent CYP3A4 inhibitor treatment within 7 days prior to the study or received a potent CYP3A4 inducer within 12 days prior to the study.
- With other active malignant tumors except HCC within 5 years or simultaneously.
- Patients are unsuitable for participation in this research after comprehensive assessment by the researchers.
- Patients participate in another clinical study at the same time.
Key Trial Info
Start Date :
September 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04443309
Start Date
September 11 2020
End Date
August 1 2024
Last Update
March 29 2023
Active Locations (1)
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1
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, Please Select, China, 100730