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Advanced CholangiocarcinomaPhase 1/2NCT03996408

Study of TQB2450 Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma

A Phase 1/2 study testing Anlotinib and TQB2450 in people with Advanced Cholangiocarcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cholangiocarcinoma
What is being tested?
Anlotinib and TQB2450
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
24 Jun 2019to 31 Mar 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.18 and 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
  • 2. Histologically or cytologically confirmed inoperable or metastatic cholangiocarcinoma.
  • 3. Providing tumor specimen obtained by biopsy or surgical sample within 2 years.
  • 4. At least one measurable lesion. 5. Has failed with standard first-line chemotherapy or were not suitable for standard first-line chemotherapy.
  • 6.The main organs function are normally. 7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
  • 8.Understood and signed an informed consent form.

Who cannot join

  • Prior therapy with VEGFR-target TKI included anlotinib or an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components.
  • Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include cured basal cell carcinoma of skin and carcinoma in situ of cervix.
  • Has any active autoimmune disease or a history of autoimmune disease.
  • Has immunosuppressive therapy with systemic or absorbable topical hormone therapy and replacement therapy for hypothyroidism with normal thyroid function within 2 weeks before the first dose.
  • Has multiple factors affecting oral medication.
Show all 13Show fewer
  • Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
  • Has any signs of bleeding or a history of physical illness.
  • Has uncontrollable symptoms of brain metastasis, spinal cord compression, cancerous meningitis during screening within 8 weeks before first dose.
  • Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks.
  • Has any serious and / or uncontrolled disease.
  • Has vaccinated with vaccines or attenuated vaccines, or received granulocyte colony stimulating factor(G -CSF)，or Granulocyte macrophage colony stimulating factor (GM-CSF) within 4 weeks prior to first dose.
  • According to the judgement of the researchers, there are other factors that may lead to the termination of the study. For example, other serious diseases including mental disorders need to be treated together, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of data and samples.

Trial locations and contacts

1 site in 1 country.

Lin Shen, Master contact

010-88196340

doctorshenlin@sina.cn

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100083

    Lin Shen, Master, 010-88196340, doctorshenlin@sina.cn

    Recruiting

Other trials in China

About this study

Official title: Phase Ib Study to Evaluate the Pharmacokinetics, Safety and Efficacy of TQB2450 Injection(PD-L1 Antibody) Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

Being tested
Anlotinib, TQB2450

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnlotinibDrug

    a multi-target receptor tyrosine kinase inhibitor

  • TQB2450Drug

    TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

Study groups in NCT03996408
Study groupRoleWhat they receive
Anlotinib + TQB2450ExperimentalTQB2450 1200 mg IV on Day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Receives: Drug: Anlotinib; Drug: TQB2450

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity (DLT)

    DLT defined as any of the following events occurring during the study related to drugs : (1) ≥grade 3 non-hematologic toxicity; (2) Grade 4 neutropenia, thrombocytopenia, and hemoglobin reduction confirmed by at least 2 tests within 2 days; Grade 3 thrombocytopenia with bleeding tendency confirmed by at least 2 tests within 2 days; (3) Grade 3 neutropenia with fever confirmed at least 2 times within 2 days.

    Measured: up to 21 days

  2. Maximum tolerated dose (MTD)

    MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT)

    Measured: up to 21 days

  3. Recommended Phase II dose (RP2D)

    The RP2D defined as the lower dose level to MTD based on the safety profile

    Measured: up to 24 months

  4. Overall response rate (ORR)

    Percentage of subjects achieving complete response (CR) and partial response (PR)

    Measured: up to 24 months

Secondary outcomes (4)

  1. Disease control rate（DCR）

    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD)

    Measured: up to 24 months

  2. Progression-free survival (PFS)

    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause

    Measured: up to 24 months

  3. Overall survival (OS)

    OS defined as the time from randomization to death from any cause. Subjects 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

    Measured: up to 24 months

  4. Adverse Event

    Number of participants with adverse events

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2019
  2. Study start24 Jun 2019
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03996408
Sponsor's protocol ID
TQB2450-Ib-08
Status last verified
Jun 2019
First submitted
21 Jun 2019
Last updated
30 Oct 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou J, Sun Y, Zhang W, Yuan J, Peng Z, Wang W, Gong J, Yang L, Cao Y, Zhao H, Chen C, Wang W, Shen L, Zhou A. Phase Ib study of anlotinib combined with TQB2450 in pretreated advanced biliary tract cancer and biomarker analysis. Hepatology. 2023 Jan 1;77(1):65-76. doi: 10.1002/hep.32548. Epub 2022 Aug 18.

    PubMed 35491432

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Anlotinib and TQB2450 in people with Advanced Cholangiocarcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lin Shen, Master (010-88196340, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) (time frame: up to 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03996408, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.

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