Safety and Efficacy Study of Sintilimab Combined With IBI305 in Patients With Advanced Hepatocellular Carcinoma

NCT04072679 | Completed Phase 1

• 1 other identifier: CIBI338B101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase Ib study to evaluate the safety, tolerability and efficacy of Sintilimab combined with IBI305 in patients with advanced hepatocellular carcinoma in China.

Conditions

Advanced Hepatocellular Carcinoma

Keywords

Advanced Hepatocellular Carcinoma; Sintilimab; IBI305

Outcome Measures

Primary Outcomes (1)

• Incicende of Adverse Events (AEs)

  Number of patients with AE, treatment-related AE (TRAE), immune-related AEs (irAE), AE of special interest (AESI), serious adverse event (SAE) assessed by CTCAE v5.0.

  2 years

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  2 years

• Time to response (TTR)

  2 years

• Duration of response (DOR)

  2 years

• Disease control rate (DCR)

  2 years

• Progression free survival (PFS)

  2 years

Study Arms (1)

Sintilimab+IBI305

EXPERIMENTAL

Sintilimab: 200mg (D1, q3w） IBI305: 7.5mg/kg or 15mg/kg (D1, q3w）

Drug: Sintilimab+IBI305

Interventions

Sintilimab+IBI305 DRUG

It includes dose escalation and dose expansion stage. 6-9 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then select specific dose of IBI305 +Sintilimab 200mg/kg, expand to 36-39 patients for the further safety and efficacy study.The study treatment lasts up to 24 months.

Sintilimab+IBI305

Eligibility Criteria

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

You may qualify if:

• Local advanced or metastatic hepatocellular carcinoma, confirmed by histology/cytology.
• Barcelona Clinic Liver Cancer (BCLC) C. BCLC B, unsuitable for local treatments or local treatments failure.
• Patients who failed to or unsuitable for the previously systemic chemotherapy, sorafenib, lenvatinib, regorafenib or similar drug failure (disease progression or toxicity intolerance).
• At least one measurable lesion per RECIST V1.1 that has not been treated locally or that has progressed after local treatment.
• Child-Pugh score ≤ 7 points.
• ECOG：0 or 1.
• Adequate organ and bone marrow function.

You may not qualify if:

• With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
• Have a history of hepatic encephalopathy or have a history of liver transplantation.
• HBV DNA\>2000 IU/ml or 104 copies/ml for acute or chronic active hepatitis B or hepatitis C; HCV RNA\>103 copies/ml; both HbsAg and anti-HCV antibody are positive.
• Esophageal or gastric varices bleeding caused by portal hypertension occurred in the past 6 months. Patients with endoscopy evidence of severe varices (G3) within 3 months. Patients with portal hypertension in high risk of bleeding evaluated by investigator.
• History of venous thromboembolism in the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other history of severe thromboembolism. Implantable IV ports or catheter-derived thrombosis, superficial venous thrombosis, or thrombosis after conventional anticoagulant therapy are excluded. Prophylactic uses of low-dose aspirin or low molecular weight heparin is allowed.
• Portal vein tumor thrombus (PVTT) involves both the main trunk and contralateral branch or upper mesenteric vein. Inferior vena cava tumor thrombus.
• Uncontrolled high blood pressure, systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg after optimal medical treatment; Hypertensive crisis or history of hypertensive encephalopathy.
• History of gastrointestinal perforation and/or fistula in the past 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) , complicated by chronic diarrhea), Crohn's disease, ulcerative colitis or long-term chronic diarrhea.
• History of interstitial pneumonia, drug-induced pneumonia, idiopathic pneumonia or active pneumonia. Allow radioactive pneumonia in the radiotherapy area.
• HIV infected (HIV 1/2 antibody positive).
• Use of immunosuppressive drugs in the past 4 weeks, excluding the routes of topical glucocorticoids or physiological doses of systemic glucocorticoids (ie no more than 10 mg/day of prednisone or equivalent). Temporary use of glucocorticoids for dyspnea symptoms such as asthma and chronic obstructive pulmonary disease is allowed.
• Have undergone major surgery (craniotomy, thoracotomy or open surgery) or unhealed wounds, ulcers or fractures within 4 weeks.
• Previously received any anti-PD-1, anti-PD-L1/L2 antibodies, anti-CTLA4 antibodies, or other immunotherapy; previously received anti-VEGF monoclonal antibody treatment.
• Female patients who are pregnant or breastfeeding.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College

Beijing, 100021, China

Location

Study Officials

• Aiping Zhou Zhou, Doctor

  National Cancer Center/Cancer Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: October 11, 2018
• Primary Completion: March 31, 2020
• Study Completion: November 11, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

CN (1)