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JS207 Plus JS007 Versus Toripalimab Plus Bevacizumab as First-Line Treatment for Advanced Liver Cancer

11. september 2026 oppdatert av: Shanghai Junshi Bioscience Co., Ltd.

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Antatt)

560

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150081
        • Harbin Medical University Cancer Hospital
        • Ta kontakt med:
          • Tongsen Zheng, Ph.D.
          • Telefonnummer: +86 15134569619
          • E-post: ztsgcp@126.com
        • Hovedetterforsker:
          • Tongsen Zheng, Ph.D.
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200032
        • Zhongshan hospital, Fudan university
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jia Fan, Ph.D.
        • Underetterforsker:
          • Guoming Shi, Ph.D.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: JS207 plus JS007
Drug:JS207, intravenous infusion Drug:JS007, intravenous infusion
Legemiddel: JS207
PD-1/VEGF bispecific antibody supplied as a lyophilized powder for intravenous infusion.
Legemiddel: JS007
CTLA-4 monoclonal antibody supplied as an injectable solution for intravenous infusion.
Aktiv komparator: Toripalimab plus bevacizumab
Drug:Toripalimab, intravenous infusion Drug:Bevacizumab, intravenous infusion
Legemiddel: Toripalimab
PD-1 monoclonal antibody supplied as an injectable solution for intravenous infusion.
Legemiddel: Bevacizumab
VEGF monoclonal antibody supplied as an injectable solution for intravenous infusion.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-Free Survival Assessed by Blinded Independent Central Review (BICR-PFS)
Tidsramme: 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)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-Free Survival Assessed by the Investigator (INV-PFS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blood Concentrations of JS207
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Etterforskere

  • Hovedetterforsker: Jia Fan, Ph.D., Fudan University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

8. oktober 2026

Primær fullføring (Antatt)

30. oktober 2029

Studiet fullført (Antatt)

30. oktober 2031

Datoer for studieregistrering

Først innsendt

11. september 2026

Først innsendt som oppfylte QC-kriteriene

11. september 2026

Først lagt ut (Faktiske)

16. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • JS207-017-III-HCC

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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