HAIC Combined With Sintilimab and Bevacizumab Biosimilar for Unresectable HCC

NCT05029973 | Unknown Phase 2

• 1 other identifier: HAICDD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To Evaluate the Efficacy and Safety of the Hepatic Arterial Infusion Chemotherapy(HAIC) Combined With Sintilimab and Bevacizumab Biosimilar in the Treatment of Patients With Unresectable Hepatocellular Carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Sintilimab; Bevacizumab Biosimilar; HAIC

Outcome Measures

Primary Outcomes (1)

• Overall response rate ( ORR)

  Defined as proportion of patients who have a best response of CR or PR

  Up to 2 years

Secondary Outcomes (6)

• Overall survival (OS)

  Up to 2 years

• Events Free Survival (EFS)

  Up to 2 years

• Surgical conversion rate

  Up to 2 years

• R0 resection rate of patients who accepted surgical resection

  Up to 2 years

• Pathological complete response (pCR) rate of patients who accepted surgical resection

  Up to 2 years

Study Arms (1)

Treatment Group

EXPERIMENTAL

HAIC Combined With Sintilimab and Bevacizumab Biosimilar

Drug: HAIC; Drug: Sintilimab; Drug: Bevacizumab Biosimilar

Interventions

HAIC DRUG

hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment

Also known as: Hepatic Artery Infusion Chemotherapy, FOLFOX

Treatment Group

Sintilimab DRUG

200mg IV d1,Q3W

Also known as: IBI308

Treatment Group

Bevacizumab Biosimilar DRUG

7.5mg/kg IV d1,Q3W

Also known as: IBI305

Treatment 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:

• Written informed consent should be signed before implementing any trial-related procedures;
• Age ranges from 18 to 75 years old.
• CNLC-IIb to IIIb HCC based on the Criteria for diagnosis and treatment of hepatocellular carcinoma (2019 edition)
• At least ≥ 1 measurable lesions per mRECIST;
• Child-Pugh grade A or B;
• ECOG PS scores 0-1;
• No prior therapy for HCC.
• Expected survival time \> 6 months;
• Sufficient organ functions, the subjects need to meet the following laboratory indicators:
• No blood transfusion, no use of hematopoietic stimulators (including g-csf, gm-csf, EPO and TPO) and infusion of human albumin preparations within 14 days prior to screening:Neutrophil absolute count ≥1.5×10\^9/L;Platelet count ≥ 100×10\^9/L;Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN); or total bilirubin \> ULN but direct bilirubin ≤ ULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 × ULN;
• Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) ≥ 60 ml/min;
• International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN
• Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, the subjects can also be included in the group in case total T3 (or FT3) and FT4 are within the normal range;

You may not qualify if:

• known as Inhibition of fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC；Previous HCC recurrence；Hepatic encephalopathy has been clinically diagnosed in the past 6 months .
• Autoimmune hepatitis (requiring liver puncture).
• History of organ transplantation or hepatic encephalopathy.
• Diffuse hepatoma.
• Clinical symptoms requiring drainage including pleural effusion, ascites, and pericardial effusion.
• History of nephropathy or nephrotic syndrome.
• Bleeding from a varicose vein in the esophagus or gastric fundus caused by portal hypertension in the past 6 months; Presence of severe (G3) varicose veins identified by endoscopy 3 months prior to initial administration; Evidence of portal hypertension (including imaging findings that the length of the spleen exceeds 10 cm and the platelets lower than 100), with a high risk of hemorrhage assessed by the investigator.
• Arteriovenous thromboembolic events in the past 6 months, including history of myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary artery embolism, deep vein thrombosis or any other serious thromboembolism. Implantable venous infusion port or catheter-derived thrombosis, or superficial venous thrombosis, except for those with stable thrombosis after conventional anticoagulation therapy.
• Severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
• Acceptance of preventive use of low-dose low-molecular-weight heparin (such as Enoxaparin 40 mg/day), except for vitamin K antagonists (such as warfarin).
• Requiring long-term medication for the inhibition of platelet function, such as aspirin, dipyridamole or clopidogrel.
• Uncontrollable hypertension, systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg after optimized medical treatment, history of critical hypertension or hypertensive encephalopathy.
• Symptomatic congestive heart failure (New York Heart Association class II-IV), symptomatic or poorly controlled arrhythmia, congenital long QT syndrome history or QTc \> 500 ms corrected at screening (calculated using the Fridericia method).
• History of gastrointestinal perforation and or fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea), Crohns disease, ulcerative colitis, or long-term chronic diarrhea in the past 6 months.
• Received major surgery (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures within 4 weeks prior to the first administration, except for received tissue biopsy or other minor surgery within 7 days prior to the first administration, venipuncture catheterization for intravenous infusion.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Folfox protocol; sintilimab

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

Huikai Li, MD

CONTACT

862223340123; lihuikai@tjmuch.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

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: September 1, 2021
• Study Start: May 10, 2021
• Primary Completion: January 10, 2022
• Study Completion: November 10, 2023
• Last Updated: February 8, 2023

Record last verified: 2022-12

Locations

CN (1)