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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. marts 2021 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

392

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Medicin: TQB2450 Injection
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.
Medicin: 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.
Medicin: Oxaliplatin injection
Oxaliplatin injection 130 mg/m2 administered IV on Day 1 of each week in 3-week cycles;
Medicin: Capecitabine tablets
Capecitabine tablets total dose 2000 mg/m2, oral twice a day from Day 1-14 of each 3- week cycles;
Medicin: Gemcitabine hydrochloride injection
Gemcitabine hydrochloride injection administered 1000 mg/m2 IV on Day 1 and Day 8 of each week in 3-week cycles.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Samlet overlevelse ved 12 måneder
Tidsramme: op til 12 måneder
Procentdel af deltagere, hvis OS har opnået mindst 12 måneder.
op til 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. februar 2021

Primær færdiggørelse (Forventet)

18. marts 2022

Studieafslutning (Forventet)

1. februar 2023

Datoer for studieregistrering

Først indsendt

19. marts 2021

Først indsendt, der opfyldte QC-kriterier

19. marts 2021

Først opslået (Faktiske)

22. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TQB2450-III-08

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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