Clinical Trials List
Protocol NumberGO44457
NCT Number(ClinicalTrials.gov Identfier)NCT05908786
2023-08-01 - 2028-06-30
Others
Recruiting5
A Phase Ib/II, Open-Label, Multicenter, Randomized Platform Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma (MORPHEUS-NEO HCC)
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 邱彥程 無
- Hsin-Yu Kuo 無
- Yih-Jyh Lin 無
- Liu Yi-Sheng 無
- Chiu Hung Chiu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Carcinoma, Hepatocellular
Objectives
The purpose of this trial is to compare the effects, good and bad, of a combination of cancer immunotherapy treatments on you and your liver cancer, to find which treatment is better. Combination cancer immunotherapy treatments are experimental drug treatments, meaning they have not been approved by health authorities for preoperative (treating cancer before surgery) treatment of liver cancer.
Test Drug
Tecentriq (RO5541267) (Atezolizumab)Avastin (RO4876646) (Bevacizumab)RO7092284 (Tiragolumab)RO7247669 (PD1-LAG3)
Active Ingredient
Atezolizumab
Bevacizumab
Tiragolumab
PD1-LAG3 BsAb
Bevacizumab
Tiragolumab
PD1-LAG3 BsAb
Dosage Form
vial
vial
vial
vial
vial
vial
vial
Dosage
1200 mg/20 ml vial
400 mg/16 ml
600 mg/10 ml
300 mg/6 ml
400 mg/16 ml
600 mg/10 ml
300 mg/6 ml
Endpoints
‧ Evaluate the efficacy of preoperative immunotherapy treatment combinations
‧MPR rate, defined as the proportion of resected subjects with an MPR <10% (residual viable tumor in the tumor bed) based on central review assessment
‧MPR rate, defined as the proportion of resected subjects with an MPR <10% (residual viable tumor in the tumor bed) based on central review assessment
Inclution Criteria
Inclusion Criteria:
Diagnosis of HCC confirmed either histologically or clinically according to AASLD criteria for patients with cirrhosis. For participants without cirrhosis, histological confirmation is mandatory.
HCC that is amenable to R0 surgical resection with curative intent in the opinion of the surgeons and oncologists or hepatologists involved in the care of the participant. Patients presenting with resectable HCC within or beyond Milan criteria (without extrahepatic spread or macrovascular invasion) are eligible.
Measurable disease (at least one target lesion) according to RECIST v1.1 as determined by the investigator
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization
Child-Pugh Class A within 7 days prior to randomization
Negative HIV test at screening
No prior locoregional or systemic treatment for HCC
Adequate hematologic and end-organ function
Documented virology status of hepatitis
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm
Diagnosis of HCC confirmed either histologically or clinically according to AASLD criteria for patients with cirrhosis. For participants without cirrhosis, histological confirmation is mandatory.
HCC that is amenable to R0 surgical resection with curative intent in the opinion of the surgeons and oncologists or hepatologists involved in the care of the participant. Patients presenting with resectable HCC within or beyond Milan criteria (without extrahepatic spread or macrovascular invasion) are eligible.
Measurable disease (at least one target lesion) according to RECIST v1.1 as determined by the investigator
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization
Child-Pugh Class A within 7 days prior to randomization
Negative HIV test at screening
No prior locoregional or systemic treatment for HCC
Adequate hematologic and end-organ function
Documented virology status of hepatitis
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm
Exclusion Criteria
General Exclusion Criteria:
Presence of extrahepatic disease or macrovascular invasion
Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC, or other rare variants of HCC
History of hepatic encephalopathy if clinically significant within one year prior to initiation of study treatment
Moderate or severe ascites
Active co-infection with HBV and HCV
Known active co-infection with HBV and hepatitis D viral infection
Prior treatment with CD137 agonists or immune checkpoint inhibitors, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
Inadequately controlled hypertension
History of hypertensive crisis or hypertensive encephalopathy
Significant vascular disease within 6 months prior to initiation of study treatment
History of hemoptysis within 1 month prior to initiation of study treatment
Evidence of bleeding diathesis or significant coagulopathy
Current or recent (<= 10 days prior to initiation of study treatment) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes
History of abdominal or tracheoesophageal fistula, GI perforation or intra-abdominal abscesses within 6 months prior to initiation of study treatment
History of intestinal obstruction and/or clinical sign or symptoms of GI obstruction
Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
Grade >= proteinuria
Major surgical procedure, open biopsy, or significant traumatic injury, or abdominal surgery, interventions or traumatic injuries, or anticipation of need of major surgical procedure other than potentially curative liver resection
Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
Serious infection requiring oral or IV antibiotics and/or hospitalization
Active tuberculosis
Presence of extrahepatic disease or macrovascular invasion
Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC, or other rare variants of HCC
History of hepatic encephalopathy if clinically significant within one year prior to initiation of study treatment
Moderate or severe ascites
Active co-infection with HBV and HCV
Known active co-infection with HBV and hepatitis D viral infection
Prior treatment with CD137 agonists or immune checkpoint inhibitors, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
Inadequately controlled hypertension
History of hypertensive crisis or hypertensive encephalopathy
Significant vascular disease within 6 months prior to initiation of study treatment
History of hemoptysis within 1 month prior to initiation of study treatment
Evidence of bleeding diathesis or significant coagulopathy
Current or recent (<= 10 days prior to initiation of study treatment) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes
History of abdominal or tracheoesophageal fistula, GI perforation or intra-abdominal abscesses within 6 months prior to initiation of study treatment
History of intestinal obstruction and/or clinical sign or symptoms of GI obstruction
Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
Grade >= proteinuria
Major surgical procedure, open biopsy, or significant traumatic injury, or abdominal surgery, interventions or traumatic injuries, or anticipation of need of major surgical procedure other than potentially curative liver resection
Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
Serious infection requiring oral or IV antibiotics and/or hospitalization
Active tuberculosis
The Estimated Number of Participants
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Taiwan
20 participants
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Global
150 participants
