JS207 Plus JS007 Versus Toripalimab Plus Bevacizumab as First-Line Treatment for Advanced Liver Cancer
A Phase III, Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of JS207 in Combination With JS007 Versus Toripalimab in Combination With Bevacizumab as First-line Treatment for Advanced Hepatocellular Carcinoma
This is a multicenter, randomized, open-label, controlled Phase III clinical study designed to evaluate the efficacy and safety of JS207 in combination with JS007 versus toripalimab in combination with bevacizumab as first-line treatment in participants with advanced HCC.
All study participants have unresectable locally advanced, recurrent, or metastatic HCC and have not previously received systemic anti-tumor therapy for advanced disease.
Approximately 560 participants are planned to be enrolled in this study. The JS207 + JS007 group (experimental group) and the toripalimab + bevacizumab group (positive control group) are each planned to enroll 280 participants.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
This is a multicenter, randomized, open-label, active-controlled Phase III study in participants with unresectable locally advanced, recurrent, or metastatic hepatocellular carcinoma.Tumor images will be assessed by investigator and blinded independent central review (BICR). Treatment will continue until protocol-defined discontinuation criteria are met, for a maximum of 2 years. Participants will undergo tumor assessments, safety assessments, and survival follow-up.
Anti-tumor activity will be assessed by determining best overall response (BOR), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (BICR-PFS and INV Safety will be assessed through AEs, laboratory variables, physical examination findings, vital signs, 12-lead electrocardiogram, echocardiography, and ECOG performance status. The severity of AEs will be graded per NCI-CTCAE v6.0.
Participants in the JS207 + JS007 group (experimental group) will undergo plasma concentration assessments and immunogenicity assessments for JS207 and JS007.
The EORTC QLQ-C30, EORTC QLQ-HCC18, and EQ-5D-5L questionnaires will be used to assess participants' health-related quality of life (HRQOL).
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Fáze 3
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Jiazheng Yan, Project Manager
- Telefonní číslo: +86 158 2259 6147
- E-mail: jiazheng_yan@junshipharma.com
Studijní záloha kontaktů
- Jméno: Feng Li
- Telefonní číslo: +86 186 2772 1499
- E-mail: feng_li@junshipharma.com
Studijní místa
-
-
Heilongjiang
-
Harbin, Heilongjiang, Čína, 150081
- Harbin Medical University Cancer Hospital
-
Kontakt:
- Tongsen Zheng, Ph.D.
- Telefonní číslo: +86 15134569619
- E-mail: ztsgcp@126.com
-
Vrchní vyšetřovatel:
- Tongsen Zheng, Ph.D.
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Čína, 200032
- Zhongshan hospital, Fudan university
-
Kontakt:
- Jia Fan, Ph.D.
- Telefonní číslo: +86 021 64041990
- E-mail: fan.jia@zs-hospital.sh.cn
-
Kontakt:
- Guoming Shi, Ph.D.
- Telefonní číslo: +86 13916969578
- E-mail: shi.guoming@zs-hospital.sh.cn
-
Vrchní vyšetřovatel:
- Jia Fan, Ph.D.
-
Dílčí vyšetřovatel:
- Guoming Shi, Ph.D.
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Voluntarily participate and sign a written informed consent form.
- Aged 18-75 years, regardless of sex.
- Histologically/cytologically confirmed HCC, or cirrhosis meeting the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC.
- No prior systemic therapy for HCC.
- At least one measurable lesion per RECIST v1.1 criteria.
- Child-Pugh liver function grade A or grade B with a score ≤7, and no history of hepatic encephalopathy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.
- Expected survival ≥ 12 weeks.
- Adequate hematologic and end-organ function.
- Female participants of childbearing potential and male participants with female partners of childbearing potential must use a highly effective contraceptive method during the study and for at least 6 months after the last dose. Female participants of childbearing potential must have a negative blood HCG test within 7 days prior to study enrollment and must not be breastfeeding.
Exclusion Criteria:
- Concomitant with the following study disease states: Known intrahepatic cholangiocarcinoma (ICC) or mixed-type liver cancer, sarcomatoid hepatocellular carcinoma, and fibrolamellar carcinoma of the liver; Presence of HCC central nervous system metastasis.
- Prior treatment-related toxicity not recovered to ≤ CTCAE Grade 1.
- Severe infection at screening.
Uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically apparent moderate or greater ascites at screening.
-≥ Grade 3 (NCI-CTCAE v6.0) gastrointestinal or non-gastrointestinal fistula at screening.
- Severe unhealed wounds, active ulcers, or untreated fractures at screening.
- Severe cardiovascular or cerebrovascular disease:
- History of gastrointestinal bleeding within 6 months prior to the first dose, or definite tendency for gastrointestinal bleeding.
- Other obvious bleeding tendency or evidence of major coagulation disorders:
- Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose.
- Malignancy other than HCC within 5 years prior to the first dose.
- Confirmed or suspected moderate-to-severe pulmonary disease severely affecting pulmonary function.
- Active tuberculosis.
- Co-infection with hepatitis B and hepatitis C.
- Known history of human immunodeficiency virus (HIV) infection, prior allogeneic stem cell or solid organ transplantation, or other immunodeficiency.
- Known history of severe allergy to any monoclonal antibody.
- Other factors that, in the investigator's judgment, may affect study results or lead to forced premature termination of the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: JS207 plus JS007
Drug:JS207, intravenous infusion Drug:JS007, intravenous infusion
|
PD-1/VEGF bispecific antibody supplied as a lyophilized powder for intravenous infusion.
CTLA-4 monoclonal antibody supplied as an injectable solution for intravenous infusion.
|
|
Aktivní komparátor: Toripalimab plus bevacizumab
Drug:Toripalimab, intravenous infusion Drug:Bevacizumab, intravenous infusion
|
PD-1 monoclonal antibody supplied as an injectable solution for intravenous infusion.
VEGF monoclonal antibody supplied as an injectable solution for intravenous infusion.
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Progression-Free Survival Assessed by Blinded Independent Central Review (BICR-PFS)
Časové okno: From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
|
Time from randomization to the first documented disease progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first.
Tumor assessments use Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Assessments are performed every 6 weeks through Week 54 and every 9 weeks thereafter.
|
From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
|
|
Overall Survival (OS)
Časové okno: From randomization to death from any cause; assessed up to 66 months.
|
Time from randomization to death from any cause.
After safety follow-up, survival status is assessed every 2 months until death, loss to follow-up, withdrawal of consent, or study termination.
|
From randomization to death from any cause; assessed up to 66 months.
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Progression-Free Survival Assessed by the Investigator (INV-PFS)
Časové okno: From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
|
Time from randomization to first documented disease progression assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurs first.
Tumor assessments use Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Assessments are performed every 6 weeks through Week 54 and every 9 weeks thereafter.
|
From randomization to disease progression or death, whichever occurs first; assessed up to 24 months.
|
|
Objective Response Rate Assessed by BICR (ORR)
Časové okno: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
Percentage of randomized participants whose best overall response is complete response (CR) or partial response (PR).
Responses and progression are assessed by blinded independent central review (BICR) per RECIST v1.1.
|
From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
|
Objective Response Rate Assessed by the Investigator (ORR)
Časové okno: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
Percentage of randomized participants whose best overall response is complete response (CR) or partial response (PR).
Responses and progression are assessed by the investigator per RECIST v1.1.
|
From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
|
Disease Control Rate Assessed by BICR (DCR)
Časové okno: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
Percentage of randomized participants whose best overall response is complete response (CR), partial response (PR), or stable disease (SD).
Responses and progression are assessed by blinded independent central review (BICR) per RECIST v1.1.
|
From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
|
Disease Control Rate Assessed by the Investigator (DCR)
Časové okno: From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
Percentage of randomized participants whose best overall response is complete response (CR), partial response (PR), or stable disease (SD).
Responses and progression are assessed by the investigator per RECIST v1.1.
|
From randomization to the end of tumor assessment follow-up; assessed up to 24 months.
|
|
Duration of Response Assessed by BICR (DoR)
Časové okno: From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
|
Time from the first documented complete response (CR) or partial response (PR) to first documented disease progression or death from any cause, whichever occurs first, among responders.
Responses and progression are assessed by blinded independent central review (BICR) per RECIST v1.1.
|
From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
|
|
Duration of Response Assessed by the Investigator (DoR)
Časové okno: From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
|
Time from the first documented complete response (CR) or partial response (PR) to first documented disease progression or death from any cause, whichever occurs first, among responders.
Responses and progression are assessed by the investigator per RECIST v1.1.
|
From first complete or partial response to progression or death, whichever occurs first; assessed up to 24 months.
|
|
Number of Participants With Adverse Events
Časové okno: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
|
Adverse events (AEs) are summarized by incidence, severity, and outcome.
Severity is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
|
From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
|
|
Number of Participants With Serious adverse events (SAEs)
Časové okno: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
|
Serious adverse events (SAEs) are summarized by incidence, severity, and outcome.
Severity is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
|
From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
|
|
Number of Participants With Immune-related AEs
Časové okno: From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
|
Immune-related AEs are summarized by incidence, severity, and outcome.
Severity is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
|
From informed consent through 90 days after the last dose or initiation of new anticancer therapy, whichever occurs first; Up to 28 months.
|
Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Blood Concentrations of JS207
Časové okno: Up to 27 months
|
Concentrations of JS207 in serum, measured using the validated bioanalytical assay.
|
Up to 27 months
|
|
Immunogenicity of JS207 assessed by the presence of antidrug antibodies (ADAs) for JS207
Časové okno: Up to 27 months
|
Presence of antidrug antibodies (ADAs) for JS207 (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
|
Up to 27 months
|
|
Immunogenicity of JS207 assessed by the presence of antidrug antibodies (NAb) for JS207
Časové okno: Up to 27 months
|
Presence of antidrug antibodies (ADAs) for JS207 (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
|
Up to 27 months
|
|
Blood Concentrations of JS007
Časové okno: Up to 27 months.
|
Concentrations of JS007 in serum, measured using the validated bioanalytical assay.
|
Up to 27 months.
|
|
Immunogenicity of JS007 assessed by the presence of antidrug antibodies (ADAs) for JS007
Časové okno: Up to 27 months.
|
Presence of antidrug antibodies (ADAs) for JS007 (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
|
Up to 27 months.
|
|
Immunogenicity of JS007 assessed by the presence of antidrug antibodies (NAb) for JS007
Časové okno: Up to 27 months
|
Presence of antidrug antibodies (ADAs) for JS007 (confirmatory results: titers and neutralizing antibodies for confirmed positive samples).
|
Up to 27 months
|
|
EORTC QLQ-C30 Scores
Časové okno: Up to 25 months
|
Patient-reported scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
Scale and item scores range from 0 to 100.
|
Up to 25 months
|
|
EORTC QLQ-HCC18 Scores
Časové okno: Up to 25 months.
|
Patient-reported scores on the EORTC hepatocellular carcinoma-specific quality-of-life questionnaire (QLQ-HCC18).
Symptom and problem scores range from 0 to 100.
|
Up to 25 months.
|
|
EQ-5D-5L
Časové okno: Up to 25 months
|
There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a visual analog scale (VAS) that measures health state.
|
Up to 25 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Jia Fan, Ph.D., Fudan University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle místa
- Novotvary
- Novotvary podle histologického typu
- Novotvary trávicího systému
- Nemoci trávicího systému
- Onemocnění jater
- Novotvary, žlázové a epiteliální
- Adenokarcinom
- Novotvary jater
- Karcinom
- Karcinom, Hepatocelulární
- Aminokyseliny, peptidy a proteiny
- Proteiny
- Protilátky, monoklonální, humanizované
- Protilátky, monoklonální
- Protilátky
- Imunoglobuliny
- Imunoproteiny
- Krevní proteiny
- Sérové globuliny
- Globuliny
- Bevacizumab
- Toripalimab
Další identifikační čísla studie
Další identifikační čísla studie
- JS207-017-III-HCC
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .