SHR-1210 Combined With Apatinib Mesylate in the Perioperative Treatment of Hepatocellular Carcinoma

NCT04297202 | Unknown Phase 2 DMC

• 1 other identifier: 2019-SR-332
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With Hepatocellular Carcinoma(HCC).This study aims to evaluate the safety and efficacy of SHR-1210 combination with Apatinib as a preoperative treatment of HCC.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; the Perioperative Treatment; HCC

Outcome Measures

Primary Outcomes (1)

• Major pathologic response

  It is defined as residual tumors less than 10% after neo-adjuvant therapy

  6 months

Secondary Outcomes (6)

• Pathological complete response

  6 months

• Objective Response(ORR)

  Before surgery；

• Recurrence free survival(RFS)

  through study completion, an average of 1 year

• Recurrence free survival rates of 6 months and 12 months

  12 months

• Overall survival rate (6 m or 12 m)

  through study completion; the rate of OS for 6 months and 12 months

Study Arms (1)

Apatinib Combined With SHR-1210 Injection

EXPERIMENTAL

SHR-1210 Injection: 3 cycles of neoadjuvant therapy before surgery, two weeks is a treatment cycle; Apatinib : D1-D21 : 250 mg, orally, qd; Before surgery, the patient's surgical pathology samples still need to be collected. D46 : Patients were preoperatively evaluated. Operable patients were scheduled for hepatectomy with/without microwave ablation; After 4 to 8 weeks after liver resection, a postoperative adjuvant program is performed. The cycle of a three-week plan will be performed with a total of 8 cycles with the treatment of Apatinib combination with SHR-1210 Injection.

Drug: Apatinib Combined With SHR-1210 Injection

Interventions

Apatinib Combined With SHR-1210 Injection DRUG

3 cycles of neoadjuvant therapy before surgery, two weeks is a treatment cycle: D1、D15、D31 : SHR-1210 200mg, I.V, q2w； D1-D20 : Apatinib 250 mg, orally, qd; D46 : Patients were preoperatively evaluated. Operable patients were scheduled for hepatectomy with/without microwave ablation; After 4 to 8 weeks after liver resection, a postoperative adjuvant program is performed. Three weeks is a treatment cycle with a total of 8 cycles In each cycle: D1: SHR-1210 200mg, I.V, q3w; D1-D21: Apatinib 250mg, orally, qd;

Apatinib Combined With SHR-1210 Injection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient volunteered to participate in the study and signed an informed consent form
• ≥18 years of age，Male or female
• Subjects are diagnosed with histologically or cytologically confirmed HCC
• Subjects haven't received any systemic treatment for HCC before admission.
• Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard
• ECOG performance status of 0 or 1
• Life expectancy ≥ 12 weeks
• Subjects are diagnosed with resectable stage IIB, stage IIIA HCC cancer.
• The main organ's function is normal and it should meet the following criteria(Excludes use of any blood components and cell growth factors during the screening period)
• Absolute neutrophil count≥1.5×109 /L
• Platelets≥80×109/L ;Hemoglobin≥9.0 g/dL; Serum albumin≥3g/dL
• Thyroid stimulating hormone (TSH)≤1.0×upper limit of normal(ULN)（If abnormal, T3 and T4 levels should be examined at the same time）
• Total bilirubin (TBIL)≤1.5×upper limit of normal (ULN); ALT and AST≤1.5×upper limit of normal(ULN); AKP≤ 2.5×upper limit of normal(ULN)
• Serum creatinine ≤1.5×ULN or creatinine clearance \> 60 mL/minute (using Cockcroft-Gault formula)

You may not qualify if:

• Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
• Be ready for or previously received organ or allogenic bone marrow transplantation
• Moderate-to-severe ascites with clinical symptoms
• History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage.
• Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment.
• Known genetic or acquired hemorrhage or thrombotic tendency.
• The patient is currently using or has recently used (within 10 days before the start of study treatment) aspirin (\> 325mg / day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel and cilostazol.
• Thrombosis or thromboembolic event within 6 months prior to the start of study treatment.
• Cardiac clinical symptom or disease that is not well controlled.
• Subjects have uncontrollable hypertension (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg), despite patients have taken the best drug treatment ；Subjects have had a hypertensive crisis or hypertensive encephalopathy
• Patient develops severe vascular disease within 6 months before the start of study treatment.
• Patients with severe, unhealed or split wounds and active ulcers or untreated fractures
• Patients who underwent surgical treatment within 4 weeks prior to the start of study treatment.
• Factors to affect oral administration (such as patients unable to swallow oral medications, malabsorption syndrome etc. situations evidently affect drug absorption).
• Patients with gastrointestinal diseases such as intestinal obstruction (including incomplete intestinal obstruction) or those who may have caused gastrointestinal bleeding, perforation or obstruction.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (1)

• Xia Y, Tang W, Qian X, Li X, Cheng F, Wang K, Zhang F, Zhang C, Li D, Song J, Zhang H, Zhao J, Yao A, Wu X, Wu C, Ji G, Liu X, Zhu F, Qin L, Xiao X, Deng Z, Kong X, Li S, Yu Y, Xi W, Deng W, Qi C, Liu H, Pu L, Wang P, Wang X. Efficacy and safety of camrelizumab plus apatinib during the perioperative period in resectable hepatocellular carcinoma: a single-arm, open label, phase II clinical trial. J Immunother Cancer. 2022 Apr;10(4):e004656. doi: 10.1136/jitc-2022-004656.

  PMID: 35379737 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

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

• Xuehao Wang

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Xuehao Wang

CONTACT

86-025-68303211; Wangxh@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: March 5, 2020
• Study Start: December 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)