TQB2450 Plus Anlotinib as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Resection

NCT05111366 | Unknown Phase 2

• 1 other identifier: 20210727
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This is An Open, Single Arm, Multicenter, Exploratory Phase II study, to evaluate the efficacy and safety of TQB2450 Plus anlotinib as adjuvant therapy in hepatocellular carcinoma(HCC) patients at high risk of recurrence after resection. The patients who are confirmed by Histology or cytology as HCC with high-risk recurrence after R0 liver resection will be enrolled. 18 cycles adjuvant treatment with TQB2450 Plus anlotinib can improve one-year recurrence free survival (RFS) rate of HCC patients after R0 surgical resection.

Conditions

Hepatocellular Carcinoma; Adjuvant Therapy

Keywords

HCC; Adjuvant Therapy; TQB2450; Anlotinib

Outcome Measures

Primary Outcomes (1)

• 1-year Recurrence-free survival (RFS) rate

  1-year RFS rate is defined as the percentage of patients who do not experience tumor recurrence or death from any cause after 1-year treatment. 1-year RFS rate is determined according to the RECIST 1.1.

  1 year after treatment

Secondary Outcomes (3)

• Adverse events (AE)

  13 months

• 1-year Overall survival (OS) rate

  1 year after treatment

• Recurrence-free survival (RFS)

  24 months

Study Arms (1)

TQB2450 injection combined with Anlotinib hydrochloride capsules

EXPERIMENTAL

Drug: TQB2450 injection; Drug: Anlotinib hydrochloride capsules

Interventions

TQB2450 injection DRUG

TQB2450 is an injection in the form of 1200mg, ivgtt, q3W.

TQB2450 injection combined with Anlotinib hydrochloride capsules

Anlotinib hydrochloride capsules DRUG

Anlotinib Hydrochloride is a capsule in the form of 8 mg,10 mg, and 12 mg, orally, once daily, 2 weeks on/1 week off.

TQB2450 injection combined with Anlotinib hydrochloride capsules

Eligibility Criteria

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

You may qualify if:

• Voluntary participation and written informed consent; • Age: 18-75 years old; ECOG PS: 0-1; The expected survival is more than 3 months;
• HCC patients underwent R0 liver resection 4\~8 weeks before enrolled; the imaging examination confirmed no recurrence and metastasis according to the RECIST1.1;
• The remaining liver volume must account for more than 40% of the standard liver volume (patients with cirrhosis), or more than 30% (patients without cirrhosis);
• Histologically or cytologically diagnosed as HCC, with any of the following high-risk recurrence conditions: a)Multiple tumor nodules( ≥4 nodules); b)Portal vein tumor thrombosis (PVTT): tumor thrombus distal to the second branches of the portal vein (vp1) and tumor thrombus in the second branches of the portal vein (vp2); c) Portal vein tumor thrombus (PVTT): tumor thrombus in a branch of the hepatic vein (vv1) and tumor thrombus in the right, middle, or left hepatic vein trunk or the short hepatic vein (vv2);
• Laboratory inspection met the following criteria: Hemoglobin (Hb) ≥ 90 g/L, Neutrophils (ANC) ≥ 1.5×10\^9/L, Platelet count (PLT) ≥ 75×10\^9/L, White blood cell count (WBC) ≥ 3×10\^9/L, Total bilirubin (TBIL) ≤ 2.0 × normal upper limit (ULN), Aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 5.0 ×ULN, Serum creatinine (Cr) ≤ 1.5× ULN, Creatinine clearance rate (CCr) ≥ 60ml/min, International Prothrombin Standardization Ratio (INR) ≤ 1.5 or Prothrombin time (PT) extension \< 4s, Thyroid-stimulating hormone (TSH) ≤ULN (patients can be enrolled if the FT3 and FT4 levels are normal);
• Liver function status Child-Pugh grade A(5-6) with no hepatoencephalopathy;
• The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill, or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it.

You may not qualify if:

• HCC with recurrence after the surgical resection until before enrollment;
• A history of liver cancer resection within 6 months before this surgery;
• Extrahepatic metastasis;
• Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma, and fibrolamellar hepatocellular carcinoma;
• Preoperative treatment with VEGF (R) inhibitors (Anlotinib, sorafenib, Lenvatinib, and so on) or immunomodulator such as anti PD-1, PD-L1, anti CTLA-4;
• Tumor thrombus in the first branch of the portal vein(vp3), tumor thrombus extension to the trunk or the opposite side branch of the portal vein(vp4), tumor thrombus to the inferior vena cava(vv3);
• Patients with chronic active HBV or HCV, HBV-DNA\>1000IU/ml, HCV-RNA\>1000 copy/ml; hepatitis B with hepatitis C infection;
• Other adjuvant therapy after surgery (except antiviral therapy) ;
• Patients with any severe and/or unable to control diseases;
• The presence of unhealed incisions or fracture;
• A history of gastrointestinal bleeding within 6 months before enrollment; abdominal fistula, gastrointestinal perforation, or abdominal abscess within 2 months before enrollment;
• Standardization Ratio (INR) \> 1.5 or Time of partial thrombin activation (APTT) \>1.5 × ULN or undergoing thrombolysis or anticoagulation therapy;
• Genetic or acquired bleeding and thrombosis tendency, such as hemophilia, coagulopathy, etc; Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism.
• History of another malignancy tumor within 5 years or for now (except for local cancer already cured).
• Patients with a history of immunodeficiency(or autoimmune disease), or other acquired congenital immunodeficiency diseases;

Sponsors & Collaborators

• Xianhai Mao: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)

Changsha, Hunan, 410005, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Central Study Contacts

Xianhai Mao, PhD

CONTACT

0086-15874957968; 927011715@qq.com

Study Design

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

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: January 6, 2022
• Primary Completion: January 20, 2024
• Study Completion: May 20, 2024
• Last Updated: May 4, 2022

Record last verified: 2022-04

Locations

CN (1)