SHR-1210 Combined With Apatinib Mesylate in the Perioperative Therapy for Hepatocellular Carcinoma

NCT04930315 | Unknown Phase 2

• 1 other identifier: CISLD-11
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to compare the efficacy and safety of camrelizumab + apatinib mesylate neoadjuvant therapy combined with camrelizumab adjuvant therapy and camrelizumab adjuvant therapy alone in patients with technically resectable hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; neoadjuvant therapy; adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• 1-year tumor recurrence-free rate

  The proportion of patients who had tumor recurrence (local, regional or distant) or death within 1 year after surgery, whichever occurred first

  Up to one years

Secondary Outcomes (8)

• Overall survival (OS)

  Up to 2 years.

• Recurrence free survival (RFS)

  Up to 1 years

• 1-year survival rate

  Up to 1 years

• R0 resection rate

  Up to 2 years.

• Major pathological response (MPR)

  Up to 2 years.

Study Arms (2)

neoadjuvant and adjuvant group

EXPERIMENTAL

Preoperative：Camrelizumab ：200mg, iv, d1, q2w, 4 cycles；apatinib：250mg, po, qd, q2w, 3 cycles Operation Postoperation 4-8 weeks，Camrelizumab ：200mg, iv, d1, q2w, Up to 8 cycles

Drug: Apatinib Mesylate; Drug: Camrelizumab

adjuvant group

ACTIVE COMPARATOR

Operation Postoperation 4-8 weeks，Camrelizumab ：200mg, iv, d1, q2w, Up to 12 cycles

Drug: Camrelizumab

Interventions

Apatinib Mesylate DRUG

250mg, po, qd, q2w in neoadjuvant and adjuvant group, before surgery

neoadjuvant and adjuvant group

Camrelizumab DRUG

200mg, iv, d1, q2w, both in two groups

adjuvant group; neoadjuvant and adjuvant group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• )Aged 18-70 years old, both genders.
• )Histologically confirmed diagnosis of HCC or strictly consistent with the clinical diagnostic criteria for HCC according to AASLD guideline
• )BCLC stage was B / C, or CNLC stage was IIa-IIIb, but technically resectable (the number of tumors was less than 7, accompanied by ipsilateral portal vein or hepatic vein tumor thrombus formation, but no main portal vein, contralateral portal vein, contralateral hepatic vein or inferior vena cava tumor thrombus, no extrahepatic metastasis, estimated residual liver volume \> 30% \[if patients with liver fibrosis, residual liver volume \> 40%\])
• )At least one measurable lesion that meet the mRECIST standard, and the lesion has not received radiotherapy, or local treatments
• )Child-Pugh score: A grade
• )ECOG PS 0-1 points.
• )The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days) :
• Neutrophils ≥1.5×109/L
• Platelet count ≥100×109/L
• Hemoglobin ≥90g/L
• Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN)
• AST or ALT levels ≤ 1.5 times the upper limit of normal value (ULN);
• Serum albumin ≥ 30 g / L
• Thyroid stimulating hormone (TSH) ≤ ULN
• Subjects who did not receive anticoagulant therapy: International standardized ratio INR or Partial thromboplastin time APTT≤1.5×ULN; subjects received prophylactic anticoagulant therapy, INR≤1.5×ULN and APTT ≤ ULN within 14 days before the start of study treatment;

You may not qualify if:

• )Known hepatobiliary cell carcinoma, mixed cell carcinoma and fibre-lamellar cell carcinoma;
• )Co-infection with hepatitis B and C, or co-infection with hepatitis B and D
• )Active malignancies other than HCC within 5 years or concurrently, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix and papillary thyroid cancer
• )Subjects has received radical hepatectomy, systemic anticancer therapy for HCC (mainly including systemic chemotherapy, molecular targeted therapy and CTLA-4, PD-1 / PD-L1 monoclonal antibody immunotherapy) and local treatment for liver, including TACE, TAE, tare or local ablation, radiotherapy, etc
• )Presence of the following within 3 months prior to study entry: myocardial infarction, severe unstable angina, NYHA class 2 or higher cardiac insufficiency, poorly controlled arrhythmias, symptomatic congestive heart failure, cerebrovascular accident.
• )Having hypertension that cannot be well controlled by antihypertensive drug therapy (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);Previous history of hypertension crisis or hypertensive encephalopathy;
• )Active pulmonary tuberculosis or pulmonary tuberculosis history
• )Subject has any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or childhood asthma have been completely relieved and may be included as adults without any intervention;Asthma requiring medical intervention with bronchodilators will not be included);
• )Interstitial lung disease history or non-infectious pneumonia requiring oral or intravenous steroid therapy
• )Subjects are receiving immunosuppressive, or systemic, or absorbable local hormone therapy for immunosuppression purposes (\>10mg/ day prednisone or other therapeutic hormones) and continue to receive such therapy within 2 weeks prior to enrollment;
• )Abnormal coagulation (INR \> 1.5 or APTT \> 1.5 x ULN) with bleeding tendency or on thrombolytic or anticoagulant therapy
• )The presence of clinically significant bleeding symptoms or a definite bleeding tendency within 3 months prior to study entry, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood +++ or more at baseline, or vasculitis. Gastroscopy was performed if fecal occult blood was positive at baseline, or if it was an observable bloody stool. If gastroscopy indicated severe esophageal varices, it could not be included
• )Known hypersensitivity to apatinib, camrelizumab or drug excipients; or severe allergic reactions to other monoclonal antibodies
• )Subject has active infection or unexplained fever of \>38.5 degrees during screening and before first administration (subject's fever due to tumor can be enrolled according to the investigator's judgment);
• )Grade III or above myelosuppression (WBC \< 1.9) × 109 / L, hemoglobin lower than 79 g / L, platelet lower than 49 g / L × 109/L）

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

apatinib; camrelizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Tingbo Liang, Dr.

  Zhejiang University

  PRINCIPAL INVESTIGATOR

• Xueli Bai, Dr.

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiwen Chen, Dr.

CONTACT

+86 19941463683; yiwenchen0705@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The chairman of the First Affiliated Hospital of Zhejiang University School of Medicine

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 18, 2021
• Study Start: September 15, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)