metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
hepatocell cancer (HCC) hepatocell cancer (HCC)
versus nivolumab alone
	nivolumab plus ipilimumab
	NCI-2018-01106, 2022 Lancet Gastroenterol Hepatol 2022; 7:208-218-. NCT03222076	RCT	hepatocell cancer (HCC)	nivolumab plus ipilimumab	nivolumab	Patients With Resectable and Potentially Resectable	14 / 13	NA	inconclusive	no statistically significant result
versus placebo
	durvalumab plus bevacizumab
	EMERALD-1, 2024 November 9, 2023 Journal of Clinical oncology, Abstract January 22,2024 NCT03778957	RCT	hepatocell cancer (HCC)	Durvalumab and Bevacizumab	placebo	patients with locoregional hepatocellular carcinoma	204 / 205	NA	conclusif	demonstrated 23 % decrease in progression or deaths (PFS) (PE)
versus sorafenib
	Tislelizumab
	RATIONALE 301, 2024 JAMA Oncol 2023; 9:1651-1659-. NCT03412773	RCT	hepatocell cancer (HCC)	tislelizumab	sorafenib	first-line treatment of unresectable hepatocellular carcinoma (HCC)	342 / 332	NA	inconclusive	inconclusive 15 % decrease in deaths (OS) (PE) non inferiority for OS demonstrate but superiority threshold not met
versus Standard of Care (SoC)
	sintilimab
	Wang, 2024 Nat Med 2024; 30:708-715-. ChiCTR2000037655	RCT	hepatocell cancer (HCC), mHCC - (neo)adjuvant (NA)	sintilimab	SOc		99 / 99	NA	conclusif	demonstrated 47 % decrease in RFS/DFS (PE) statistically significant 200.0-fold increase in AE (any grade) statistically significant 26.2-fold increase in AE (grade 3-4)
mHCC - (neo)adjuvant (NA) metastatic/advanced hepatocellular cancer (mHCC) mHCC - (neo)adjuvant (NA)
versus nivolumab alone
	nivolumab plus ipilimumab
	NCI-2018-01106, 2022 Lancet Gastroenterol Hepatol 2022; 7:208-218-. NCT03222076	RCT	hepatocell cancer (HCC)	nivolumab plus ipilimumab	nivolumab	Patients With Resectable and Potentially Resectable	14 / 13	NA	inconclusive	no statistically significant result
versus Standard of Care (SoC)
	atezolizumab plus bevacizumab
	IMbrave050, 2023 Lancet 2023; 402:1835-1847-. NCT04102098	RCT	mHCC - (neo)adjuvant (NA)	atezolizumab plus bevacizumab	active surveillance	adult patients with high-risk surgically resected or ablated hepatocellular carcinoma	334 / 334	NA	conclusif	demonstrated 28 % decrease in RFS/DFS (PE)
	sintilimab
	Wang, 2024 Nat Med 2024; 30:708-715-. ChiCTR2000037655	RCT	hepatocell cancer (HCC), mHCC - (neo)adjuvant (NA)	sintilimab	SOc		99 / 99	NA	conclusif	demonstrated 47 % decrease in RFS/DFS (PE) statistically significant 200.0-fold increase in AE (any grade) statistically significant 26.2-fold increase in AE (grade 3-4)
mHCC - 1st line (L1) metastatic/advanced hepatocellular cancer (mHCC) mHCC - 1st line (L1)
versus lenvatinib
	pembrolizumab plus lenvatinib
	LEAP 002, 2023 Future Oncol 2021 Feb;17(6):637-648. Lancet Oncol 2023; 24:1399-1410-. NCT03713593	RCT	mHCC - 1st line (L1)	lenvatinib in combination with pembrolizumab	Lenvatinib	first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants	395 / 399	low	inconclusive	inconclusive 16 % decrease in deaths (OS),deaths (OS) (PE) inconclusive 13 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)
versus placebo
	durvalumab plus bevacizumab
	EMERALD-1, 2024 November 9, 2023 Journal of Clinical oncology, Abstract January 22,2024 NCT03778957	RCT	hepatocell cancer (HCC)	Durvalumab and Bevacizumab	placebo	patients with locoregional hepatocellular carcinoma	204 / 205	NA	conclusif	demonstrated 23 % decrease in progression or deaths (PFS) (PE)
versus sorafenib
	atezolizumab plus bevacizumab
	IMbrave-150, 2020 N. Engl. J. Med. 2020; 382:1894-1905 The Lancet Oncology J Hepatol 2022; 76:862-873-. NCT03434379	RCT	mHCC - 1st line (L1)	atezolizumab-bevacizumab	sorafenib	patients with unresectable hepatocellular carcinoma who had not previously received systemic treatment	336 / 165	some concern	conclusif	demonstrated 42 % decrease in deaths (OS) (PE) demonstrated 41 % decrease in progression or deaths (PFS) (PE) demonstrated 1.8-fold increase in objective responses (ORR) (PE)
	atezolizumab plus cabozantinib
	COSMIC-312, 2023 Future Oncol 2020 Jul;16(21):1525-1536. Annals of Oncology Lancet Gastroenterol Hepatol 2024; 9:310-322-. Lancet Oncol 2022; 23:995-1008-. NCT03755791	RCT	mHCC - 1st line (L1)	cabozantinib plus atezolizumab	sorafenib	Subjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy	432 / 217	NA	trade-off	inconclusive 2 % decrease in deaths (OS) (PE) demonstrated 37 % decrease in progression or deaths (PFS) (PE)
	bevacizumab, sintilimab
	ORIENT-32, 2021 NCT03794440	RCT	mHCC - 1st line (L1)	Sintilimab plus IBI305 (bevaciumab biosimilar)	Sorafenib	patients with unresectable, locally advanced, or metastatic hepato cellular carcinoma, with a diagnosis that was histologically, cytologically, or clinically confirmed, who had received no previous systemic therapy for advanced or metastatic disease, or were unsuitable for radical surgery or had local treatment stage B	380 / 191	low	conclusif	demonstrated 43 % decrease in deaths (OS),deaths (OS) (PE)
	durvalumab plus tremelimumab
	HIMALAYA, 2022 journal of clinical oncology January 19, 2022 Clin Cancer Res 2024; 30:269-273-. Annals of Oncology, 2024, NEJM Evid 2022;1(8 NCT03298451	RCT	mHCC - 1st line (L1)	durvalumab and tremelimumab	sorafenib	unresectable hepatocellular carcinoma who were naive to previous systemic treatment	393 / 389	low	conclusif	demonstrated 22 % decrease in deaths (OS) (PE) suggested 22 % decrease in deaths (OS) (extension)
	nivolumab alone
	CheckMate 459, 2019 Annals of Oncology 2019 Lancet Oncol 2022 Jan;23(1):77-90. NCT02576509	RCT	mHCC - 1st line (L1)	nivolumab	sorafenib	first-line (1L) treatment in patients (pts) with advanced hepatocellular carcinoma (aHCC) / patients (at least 18yr) with hiistologically confirmed advanced hepatocellular carcinoma ot eligible for, or whose disease had progressed after, surgical or locoregional therapies	371 / 372	some concern	suggested	inconclusive 15 % decrease in deaths (OS) (PE)
	Tislelizumab
	RATIONALE 301, 2024 JAMA Oncol 2023; 9:1651-1659-. NCT03412773	RCT	hepatocell cancer (HCC)	tislelizumab	sorafenib	first-line treatment of unresectable hepatocellular carcinoma (HCC)	342 / 332	NA	inconclusive	inconclusive 15 % decrease in deaths (OS) (PE) non inferiority for OS demonstrate but superiority threshold not met
	camrelizumab based treatment, VEGF(R) inhibitor
	CARES-310, 2023 Lancet 2023; 402:1133-1146-. NCT03764293	RCT	mHCC - 1st line (L1)	camrelizumab and rivoceranib (=apatinib)	sorafenib	adult with confirmed hepatocellular carcinoma; had Barcelona Clinic Liver Cancer stage B or C disease, which was not amenable to or had progressed after surgical or locoregional therapy; and had not previously received any systemic therapy	272 / 271	NA	conclusif	demonstrated 38 % decrease in deaths (OS),deaths (OS) (PE) demonstrated 48 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE) suggested 46 % decrease in PFS (extension),PFS (extension)
mHCC - 2nd line (L2) metastatic/advanced hepatocellular cancer (mHCC) mHCC - 2nd line (L2)
versus placebo
	pembrolizumab alone
	KEYNOTE-240, 2020 J. Clin. Oncol. 2020; 38:193-202 Cancer 2020 Nov 24. Liver Cancer 2021 Jun;10(3):275-284. NCT02702401	RCT	mHCC - 2nd line (L2)	pembrolizumab	placebo	previously treated patients with advanced hepatocellular carcinoma (HCC)	278 / 135	low	inconclusive	suggested 22 % decrease in deaths (OS),deaths (OS) (PE) suggested 28 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)

hepatocell cancer (HCC) hepatocell cancer (HCC)

mHCC - (neo)adjuvant (NA) metastatic/advanced hepatocellular cancer (mHCC) mHCC - (neo)adjuvant (NA)

mHCC - 1st line (L1) metastatic/advanced hepatocellular cancer (mHCC) mHCC - 1st line (L1)

mHCC - 2nd line (L2) metastatic/advanced hepatocellular cancer (mHCC) mHCC - 2nd line (L2)