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A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule as Second-line Treatment in Subjects With Advanced Biliary Cancer

19. mars 2021 oppdatert av: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Randomized, Open-label, Parallel Controlled, Multi-center Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Chemotherapy as Second-line Treatment in Subjects With Advanced Biliary Cancer

This study is a randomized, parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus chemotherapy as second-line treatment in subjects with advanced biliary cancer.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

392

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Kina
    • Anhui
      • Hefei, Anhui, Kina, 230001
        • Har ikke rekruttert ennå
        • Anhui Provincal Hospital
        • Ta kontakt med:
    • Beijing
      • Beijing, Beijing, Kina, 100044
        • Har ikke rekruttert ennå
        • Peking University People's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Lei Chen, Doctor
      • Beijing, Beijing, Kina, 100021
        • Har ikke rekruttert ennå
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Hovedetterforsker:
          • Aiping Zhou, Doctor
        • Ta kontakt med:
      • Beijing, Beijing, Kina, 102218
        • Har ikke rekruttert ennå
        • Beijing Tsinghua Changgung Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jiahong Dong, Doctor
      • Beijing, Beijing, Kina, 100089
        • Rekruttering
        • Beijing Cancer Hospital
      • Beijing, Beijing, Kina, 100020
        • Har ikke rekruttert ennå
        • Beijing Chao-Yang Hospital,Capital Medical University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Guangyu An, Doctor
      • Beijing, Beijing, Kina, 100069
        • Har ikke rekruttert ennå
        • Beijing Youan Hospital,Captical Medical University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dondong Lin, Doctor
    • Fujian
      • Fuzhou, Fujian, Kina, 350001
        • Har ikke rekruttert ennå
        • Fujian Medical University Union Hospital
        • Ta kontakt med:
    • Hebei
      • Baoding, Hebei, Kina, 071000
        • Har ikke rekruttert ennå
        • Affiliated Hospital of Hebei University
        • Hovedetterforsker:
          • Aimin Zang, master
        • Ta kontakt med:
      • Cangzhou, Hebei, Kina, 061001
        • Har ikke rekruttert ennå
        • Cangzhou Central Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jinghua Gao, bachelor
      • Chengde, Hebei, Kina, 067000
        • Har ikke rekruttert ennå
        • Affiliated Hospital of Chengde Medical University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Qingshan Li, bachelor
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150081
        • Har ikke rekruttert ennå
        • Harbin medical university affiliated tumor hospital
        • Hovedetterforsker:
          • Yanqiao Zhang, Doctor
        • Ta kontakt med:
    • Henan
      • Zhengzhou, Henan, Kina, 450003
        • Har ikke rekruttert ennå
        • Henan Tumor Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Xiaobing Chen, Doctor
    • Hubei
      • Wuhan, Hubei, Kina, 430040
        • Har ikke rekruttert ennå
        • TongJi Medical College of HUST
        • Ta kontakt med:
        • Hovedetterforsker:
          • Hong Qiu, Doctor
    • Hunan
      • Changsha, Hunan, Kina, 410000
        • Har ikke rekruttert ennå
        • Hunan Provincial People's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Chuang Peng, Doctor
    • Jiangsu
      • Changzhou, Jiangsu, Kina, 213000
        • Har ikke rekruttert ennå
        • The First Peoples Hospital of Changzhou
        • Ta kontakt med:
        • Hovedetterforsker:
          • Haijiao Yan, Doctor
    • Jilin
      • Changchun, Jilin, Kina, 130000
        • Har ikke rekruttert ennå
        • The First Bethune Hospital of Jilin University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Wei Li, Doctor

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 1. Histologically or cytologically confirmed biliary adenocarcinoma, including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC) and gallbladder cancer (GBC).

2.18 years and older,Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months;Weight ≥40 kg or BMI ≥18.5.

3. At least one measurable lesion (based on RECIST 1.1). 4. Previous first-line gemcitabine or fluorouracil-based combination chemotherapy failed.

5.Adequate laboratory indicators. 6. No pregnant or breastfeeding women, and a negative pregnancy test. 7. Understood and Signed an informed consent form.

Exclusion Criteria:

  • 1. Tumor disease and medical history:

    1. Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
    2. Has other malignant tumors within 5 years;
    3. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear;
    4. Severe bone damage caused by tumor bone metastasis;
    5. Has uncontrolled and repeated drainage pleural effusion, pericardial effusion, and ascites;
    6. Partial or complete intestinal obstruction and complete biliary obstruction that cannot be relieved; 2. Previous anti-tumor therapy:
    1. Has received Anlotinib Hydrochloride Capsules, Bevacizumab Injection, and immune checkpoint inhibitors such as PD-1, PD-L1, and CTLA-4 in prior treatment;
    2. Have received anti-tumor therapy within 4 weeks before the first administration;
    3. Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy; 3.Comorbidities and medical history:
    1. Active hepatitis B or C;
    2. Kidney abnormalities;
    3. Abnormal thyroid function;
    4. Cardiovascular abnormalities;
    5. Gastrointestinal abnormalities;
    6. History of immunodeficiency;
    7. Has risk of bleeding;
    8. Uncontrollable active bacterial, fungal or viral infections;
    9. Lung diseases, such as interstitial pneumonia, obstructive lung disease, and history of symptomatic bronchospasm;
    10. Allergies to the ingredients of the study drug;
    11. Have a history of neurological or psychiatric disorders
    12. According to the researcher's point of view, other severe, acute or chronic medical or mental illnesses or laboratory abnormalities that may increase the risks associated with participating in the study, or may interfere with the interpretation of the study results;
    13. Have a history of pituitary or adrenal dysfunction
    14. Has received major surgical treatment, open biopsy, or obvious traumatic injury within 28 days before the first administration;
    15. Long-term unhealed wound or fracture;

    16. Has drug abuse history that unable to abstain from or mental disorders; 4. Has participated in other clinical trials within 30 days before the study. 5. Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration.

      6. Pregnant or breastfeeding women. 7. According to the judgement of the investigators, there are other factors that may lead to the 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: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: TQB2450+Anlotinib
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Legemiddel: TQB2450 Injection
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.
Legemiddel: Anlotinib hydrochloride
Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Aktiv komparator: Chemotherapy
Capecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection. Each cycle is 3 weeks.
Legemiddel: Oxaliplatin injection
Oxaliplatin injection 130 mg/m2 administered IV on Day 1 of each week in 3-week cycles;
Legemiddel: Capecitabine tablets
Capecitabine tablets total dose 2000 mg/m2, oral twice a day from Day 1-14 of each 3- week cycles;
Legemiddel: Gemcitabine hydrochloride injection
Gemcitabine hydrochloride injection administered 1000 mg/m2 IV on Day 1 and Day 8 of each week in 3-week cycles.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall survival (OS)
Tidsramme: up to 40 weeks
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
up to 40 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total overlevelse ved 12 måneder
Tidsramme: opptil 12 måneder
Prosentandel av deltakere hvis OS har oppnådd minst 12 måneder.
opptil 12 måneder
Progression free survival (PFS)
Tidsramme: up to 24 weeks
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
up to 24 weeks
Overall response rate (ORR)
Tidsramme: up to 24 weeks
Percentage of participants achieving complete response (CR) and partial response (PR).
up to 24 weeks
Disease control rate（DCR）
Tidsramme: up to 24 weeks
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
up to 24 weeks
Duration of response（DOR）
Tidsramme: up to 24 weeks
The time when the participants first achieved complete or partial remission to disease progression.
up to 24 weeks
Progression-free survival at 6 months
Tidsramme: up to 6 months
Percentage of participants whose PFS has achieved at least 6 months.
up to 6 months
Overall survival at 6 months
Tidsramme: up to 6 months
Percentage of participants whose OS has achieved at least 6 months.
up to 6 months

Samarbeidspartnere og etterforskere

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

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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 (Faktiske)

4. februar 2021

Primær fullføring (Forventet)

18. mars 2022

Studiet fullført (Forventet)

1. februar 2023

Datoer for studieregistrering

Først innsendt

19. mars 2021

Først innsendt som oppfylte QC-kriteriene

19. mars 2021

Først lagt ut (Faktiske)

22. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TQB2450-III-08

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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