Clinical Trials List
Protocol NumberGO44457
NCT Number(ClinicalTrials.gov Identfier)NCT05908786
Not yet recruiting
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
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- TENG-YU LEE Digestive System Department
- 黃儀倢 Digestive System Department
- 蘇德晟 Digestive System Department
- 吳峯旭 Digestive System Department
- YI-JU CHEN Digestive System Department
- 蔡忻儒 Digestive System Department
- CHUNG-HSIN CHANG Digestive System Department
- 呂宜達 Digestive System Department
- 陳家昌 Digestive System Department
- SHAO-CIAO LUO Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- YU-YUN SHAO Digestive System Department
- Chiun Hsu Digestive System Department
- - - Digestive System Department
- 何承懋 Digestive System Department
- Shih-Jer Hsu Digestive System Department
- 吳志宏 Digestive System Department
- JA-DER LIANG Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Gar-Yang Chau Digestive System Department
- I-Cheng Lee Digestive System Department
- Chien-An Liu Digestive System Department
- 周書正 Digestive System Department
- Hao-Jan Lei Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Ting-Tsung Chang
Co-Principal Investigator
- Hsin-Yu Kuo Digestive System Department
- Chiu Hung Chiu Digestive System Department
- Yih-Jyh Lin Digestive System Department
- Liu Yi-Sheng Digestive System Department
- 邱彥程 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Carcinoma, Hepatocellular
Objectives
The purpose of this trial is to compare the effects of cancer immunotherapy combined with other treatments on you and your liver cancer, both positive and negative, in order to identify the best treatment approach. Cancer immunotherapy combined with other treatments is an experimental drug therapy, meaning that these drugs have not yet been approved by health authorities for preoperative (treating cancer before surgery) treatment of liver cancer.
Test Drug
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Active Ingredient
Atezolizumab
bevacizumab
tiragolumab
RO7247669
bevacizumab
tiragolumab
RO7247669
Dosage Form
27D
27D
27D
27D
27D
27D
27D
Dosage
1200mg/20ml
400mg/16ml
600mg/10ml
300mg/6ml
400mg/16ml
600mg/10ml
300mg/6ml
Endpoints
• Evaluate the efficacy of preoperative immunotherapy combination therapy
• MPR rate, defined as the proportion of resected subjects with an MPR < 10% (residual viable tumor in the tumor bed) according to central review assessment.
• MPR rate, defined as the proportion of resected subjects with an MPR < 10% (residual viable tumor in the tumor bed) according to 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
16 participants
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Global
150 participants
