Evidence map›Paper›PMID 37858184›Full record

Trial reportBMC medicine2023

Combination of GT90001 and nivolumab in patients with advanced hepatocellular carcinoma: a multicenter, single-arm, phase 1b/2 study.

Chiun Hsu, Yi-Fang Chang, Chia-Jui Yen, Yu-Wei Xu, Min Dong, You-Zhi Tong

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03893695 (Combination of GT90001 and Nivolumab in Patients With Metastatic Hepatocellular Carcinoma), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.2field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03893695 phase1 / phase2completednot on this map

Combination of GT90001 and Nivolumab in Patients With Metastatic Hepatocellular Carcinoma

TypeinterventionalSponsorSuzhou Kintor Pharmaceutical Inc,Ran2019 to 2022Enrolled20ConditionsMetastatic Hepatocellular Carcinoma, HCC, Combinations of Drugs, DependenceArmsGT90001 and Nivolumab
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 11 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Chiun HsuDepartment of Medical Oncology, National Taiwan University Cancer Center, No. 57, Ln. 155, Sec. 3, Keelung Road., Da'an Dist., Taipei, 106, Taiwan. hsuchiun@ntu.edu.tw.
Yi-Fang ChangDepartment of Hematology and Oncology, Mackay Memorial Hospital, Taipei, Taiwan.
Chia-Jui YenDepartment of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Taipei, Taiwan.
Yu-Wei XuSuzhou Kintor Pharmaceuticals, Inc., Suzhou, China.
Min DongSuzhou Kintor Pharmaceuticals, Inc., Suzhou, China.
You-Zhi TongSuzhou Kintor Pharmaceuticals, Inc., Suzhou, China.
Mackay Memorial Hospital · TWNational Cheng Kung University Hospital · TWNational Taiwan University · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGT90001 (also known as PF-03446962) is an anti-ALK-1 monoclonal antibody and has shown activity in hepatocellular carcinoma (HCC). This phase 1b/2 study was designed to determine the recommended phase 2 dose (RP2D) of GT90001 plus nivolumab, and assess the safety and anti-tumor activity in patients with advanced HCC.

methodsPatients with advanced HCC were recruited from 3 centers. Eligible patients in the dose de-escalation stage received the GT90001 on day 1 of a 14-day cycle in a rolling-six design with a fixed dose of nivolumab (3.0 mg/kg). Patients in dose-expansion stage received the RP2D of GT90001 plus nivolumab. Primary endpoint was safety. Key secondary endpoint was objective response rate (ORR) as per RECIST 1.1.

resultsBetween July 9, 2019, and August 8, 2022, 20 patients were treated (6 in phase 1b; 14 in phase 2) and evaluable for analysis. In phase 1b, no dose-limiting toxicities were observed, and GT90001 7.0 mg/kg was confirmed as the RP2D. Common grade 3/4 adverse events (AEs) were platelet count decreased (15%). No deaths due to AEs were reported. Confirmed ORR and disease control rate were 30% (95% CI, 14.6%-51.9%) and 40% (95% CI, 21.9%-61.3%), respectively. Median duration of response was not calculated (95% CI, 7.39 months to not calculated). Median progression-free survival (PFS) was 2.81 months (95% CI, 1.71-9.33), with 6-month and 12-month PFS rates of 35% and 25%, respectively. One patient with multiple intra- and extra-hepatic metastases was diagnosed with pseudo-progression upon GT90001 plus nivolumab exposure.

conclusionsGT90001 plus nivolumab has a manageable safety profile and promising anti-tumor activity in patients with advanced HCC. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT03893695.

Indexed as

Carcinoma, HepatocellularLiver NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsHumansNivolumabProgression-Free SurvivalNivolumabAnti-angiogenic therapyGT90001Hepatocellular carcinomaImmunotherapyNivolumabPF-03446962

Identifiers

PMID37858184
PMCPMC10588186
OpenAlexW4387768841

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.