UnknownPhase 1/2

The Effectiveness and Safety of Camrelizumab/Lenvatinib Combined With TACE in Patients With Borderline Resectable HCC

China49 participantsStarted 2021-09-01

Plain-language summary

The effectiveness and safety of carmelizumab/lenvatinib combined with TACE in patients with borderline resectable hepatocellular carcinoma remain unknown. This subject is an open, single-arm, randomized, single-center, and phase Ib/II study according to simon's two phase design. In the phase Ib trial, the groups of patients were divided according to the frequency of camrelizumab: camrelizumab (q3w) plus lenvatinib and TACE group, certolizumab (q2w) plus lenvatinib and TACE group. In the phase II trial, the enrolled patients received camrelizumab/lenvatinib combined with TACE treatment (a relatively safer treatment plan based on phase Ib), and the first imaging efficacy evaluation was performed at 6-8 weeks for evaluation of surgical resection. If surgical resection is not possible, it is necessary to evaluate whether to continue TACE treatment. Afterwards, the imaging efficacy evaluation (RECISTv1.1) will be carried out every 6-8 weeks to evaluate whether to operate and determine the best operation time. If surgery is possible, choose to continue the treatment with camrelizumab and/or TACE according to the patient's condition after the operation until the disease progresses or intolerable toxicity, and the drug should be discontinued up to 2 years. Imaging examinations will be performed every 2-3 months within six months after the operation, and imaging examinations will be performed every 3-6 months after six months. Safety is based on physical examination, laboratory examination, drug-related adverse events, surgery-related adverse events, and serious adverse events. To explore the effectiveness and safety of camrelizumab/lenvatinib combined with TACE in patients with borderline resectable hepatocellular carcinoma, and to screen the predictive indicators of the efficacy and safety of the combined regimen.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age: 18-75 years old;
✓. HCC patients who have been pathologically diagnosed or meet the clinical diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Regulations (2019 Edition)" issued by the National Health Commission of China.
✓. Borderline resectable HCC patients \[1. The diameter of a single tumor\>10 cm; 2. The number of tumors was 2-3 and the maximum diameter of any lesion\>3 cm; 3. The number of nodules≥4; 4. The number of liver segments\>2 and still confined to the half liver; 5. The lesion invades large blood vessels or is less than 1 cm away from the large blood vessels; 6. Portal vein cancer thrombosis Cheng's classification I/II; 7. No extrahepatic metastases\];
✓. Estimated survival period ≥ 3 months;
✓. ECOG PS score 0-1 points;
✓. Grading of liver function: Child A;
✓. Have not received any anti-tumor system therapy (including chemotherapy, targeted drugs, immune monitoring point inhibitors, etc.) and local treatments (including HAIC, TACE, radiofrequency ablation, PVE, TARE, radiotherapy, etc.);
✓. The main organ functions are normal, and the laboratory examination results within 7 days before enrollment meet the following conditions: White blood cells (WBC) ≥ 2.5×10\^9/L, neutrophils (ANC) ≥ 1.5×10\^9/L, platelets (PLT) ≥ 75×10\^9/L, hemoglobin (HGB) ≥ 90g/L (without blood transfusion within 7 days or EPO tolerance); total bilirubin (TBI) ≤1.5×upper limit of normal range (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN; albumin ≥ 30g/L (not allowed within 14 days Supplement albumin or branched-chain amino acids); INR ≤1.5×ULN; blood creatinine (Cr) ≤1.5×ULN; urine protein ≤1+;

What they're measuring

Adverse events

Timeframe: through study completion, an average of 1 year

MPR

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05042336

SponsorSichuan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-01

Contact for this trial

Qiu Li, MD

02885422952 liqiu@scu.edu.cn

View on ClinicalTrials.gov More Carrelizumab Plus Lenvatinib Combined With TACE trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age: 18-75 years old;
✓. HCC patients who have been pathologically diagnosed or meet the clinical diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Regulations (2019 Edition)" issued by the National Health Commission of China.
✓. Borderline resectable HCC patients \[1. The diameter of a single tumor\>10 cm; 2. The number of tumors was 2-3 and the maximum diameter of any lesion\>3 cm; 3. The number of nodules≥4; 4. The number of liver segments\>2 and still confined to the half liver; 5. The lesion invades large blood vessels or is less than 1 cm away from the large blood vessels; 6. Portal vein cancer thrombosis Cheng's classification I/II; 7. No extrahepatic metastases\];
✓. Estimated survival period ≥ 3 months;
✓. ECOG PS score 0-1 points;
✓. Grading of liver function: Child A;
✓. Have not received any anti-tumor system therapy (including chemotherapy, targeted drugs, immune monitoring point inhibitors, etc.) and local treatments (including HAIC, TACE, radiofrequency ablation, PVE, TARE, radiotherapy, etc.);
✓. The main organ functions are normal, and the laboratory examination results within 7 days before enrollment meet the following conditions: White blood cells (WBC) ≥ 2.5×10\^9/L, neutrophils (ANC) ≥ 1.5×10\^9/L, platelets (PLT) ≥ 75×10\^9/L, hemoglobin (HGB) ≥ 90g/L (without blood transfusion within 7 days or EPO tolerance); total bilirubin (TBI) ≤1.5×upper limit of normal range (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN; albumin ≥ 30g/L (not allowed within 14 days Supplement albumin or branched-chain amino acids); INR ≤1.5×ULN; blood creatinine (Cr) ≤1.5×ULN; urine protein ≤1+;

The Effectiveness and Safety of Camrelizumab/Lenvatinib Combined With TACE in Patients With Borderline Resectable HCC

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

The Effectiveness and Safety of Camrelizumab/Lenvatinib Combined With TACE in Patients With Borderline Resectable HCC

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria