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Urothelial CarcinomaPhase 2NCT05030077

Anlotinib Combined With Platinum/Gemcitabine for First Line Treatment of Advanced Urothelial Carcinoma

A Phase 2 study testing Anlotinib, Cisplatin and Carboplatin in people with Urothelial Carcinoma and Anlotinib, run by Tianjin Medical University Second Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Anlotinib is a novel oral multitarget tyrosine kinase inhibitor and primary targeted to VEGFR, FGFR, PDGFR and c-Kit. This study intends to assess the efficacy and safety of anlotinib combined with platinum/gemcitabine for first line treatment of advanced urothelial carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Anlotinib, Cisplatin and Carboplatin
How many people
53 participants
Where
1 siteChina
Study dates
1 Oct 2021to 1 Sep 2024
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 years, ECOG PS: 0-1.
  • Unresectable or metastatic urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
  • At least one measurable lesion according to RECIST 1.1.
  • The main organ function meets the following criteria within 7 days before enrollment:
  • Blood tests are subject to the following criteria (without blood transfusion within 14 days): hemoglobin (HB) ≥ 90g / L; neutrophil absolute value (ANC) ≥ 1.5 × 109 / L; platelets (PLT) ≥ 80 × 109 / L.
  • Biochemical tests are subject to the following criteria: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5ULN, such as with liver metastasis, then ALT and AST ≤ 5ULN; serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min.
  • Women of childbearing age must have taken reliable contraceptive measures and performed a pregnancy test (serum) within 3 days prior to enrollment, and the results were negative, and were willing to use appropriate methods during the trial and 180 days after the last administration of the test drug.
  • Patients voluntarily joined the study and signed informed consent, with good adherence and follow-up.

Who cannot join

  • Pregnant or lactating women.
  • A history of hypersensitivity to the study drugs.
  • Patients have received systemic treatment.
  • Patients with uncontrolled or high-load central nervous system metastases (or with obvious symptoms)
  • Patients with other diseases, including:
  • Hypertension and uncontrollable levels of normal anti-hypertensive medication: systolic blood pressure≥150 mmHg, diastolic blood pressure≥90 mmHg.
Show all 23Show fewer
  • Unstable angina, newly diagnosed with angina or acute myocardial infarction within 6 months prior to enrollment, arrhythmia ( including: QTcF of male≥450ms ) requires medical intervention congestive heart failure (New York Heart Association (NYHA)≥2)
  • Active or uncontrollable infections (CTCAE 5.0≥2)
  • Known history of human immunodeficiency virus infection (HIV, congenital immune deficiency disease, or a history of organ transplantation)
  • Urinary protein ≥ ++ or 24 hours urine protein > 1 g
  • Any malignant tumor within 5 years, except those who have been cured or stabilized.
  • Uncured adverse events (NCI-CTCAE 5.0 grade II or greater) due to any treatment before, except for alopecia.
  • There are many factors that affect oral drug absorption (such as inability to swallow, Postgastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.).
  • Abnormal blood coagulation (PT>16s、APTT>43s、TT>21s、Fbg<2g/L), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy. Under the premise of an odds ratio (INR) ≤ 1.5, low-dose heparin (1mg daily) or low-dose aspirin (daily dose ≤ 100 mg) is allowed for preventive purposes.
  • Patients who underwent major surgical treatment, open biopsy, or significant traumatic injury within the first 4 weeks of enrollment.
  • Patients whose tumor has radiographically invaded an important vessel or whose tumor is determined by the investigators to be at high risk of incurring an important vessel and causing fatal hemorrhages during the study period.
  • Patients who have seizures and need treatment.
  • Patients with any signs of hemorrhage or history, regardless of severity; patients with any bleeding or bleeding episodes (NCI-CTCAE 5.0 grade III) within 4 weeks prior to grouping have unhealed wounds, ulcers, or fractures.
  • Artery or venous thrombosis occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism.
  • Patients have been inoculated with attenuated live vaccine within 28 days before enrollment or plan to inoculate vaccine during the trial.
  • Other systemic diseases that can't be controlled (such as diabetes, etc.).
  • Patients with other serious physical or mental illness or laboratory abnormalities that may increase the risk of participating in the study or interfere with the results of the study, as well as patients that the investigator considers unfit to participate in the study.
  • Patients who have participated in clinical trials of other antitumor drugs within four weeks.

Trial locations and contacts

1 site in 1 country.

Hailong Hu, MD,PhD contact

0086-13662096232

Hhllove2004@163.com

Yuanjie Niu, MD,PhD contact

0086-13821827881

niuyuanjie9317@163.com

China1 site

  • Tianjin Medical Unversity Second Hospital

    Tianjin, 300211

    Hailong Hu, MD,PhD, 0086-13662096232, Hhllove2004@163.com

Other trials in China

About this study

Official title: A Single-arm, Phase II Study of Anlotinib Combined With Platinum/Gemcitabine for First Line Treatment of Advanced Urothelial Carcinoma

Anlotinib is a novel oral multitarget tyrosine kinase inhibitor and primary targeted to VEGFR, FGFR, PDGFR and c-Kit. This study intends to assess the efficacy and safety of anlotinib combined with platinum/gemcitabine for first line treatment of advanced urothelial carcinoma.

Read the detailed description

The primary objective is to determine the antitumor activity of anlotinib combined with platinum/gemcitabine (Objective Response rate, ORR) in patients with advanced urothelial carcinoma.

Keywords
Urothelial Carcinoma, Chemotherapy, Anlotinib
Medical subject headings
Carcinoma, Transitional Cell, Urogenital Neoplasms

What participants receive

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

  • AnlotinibDrug

    Also called AL3818

    Anlotinib(12mg) oral daily for days 1-14, 21 days per cycle

  • CisplatinDrug

    Cisplatin (70 mg/m2) IV day 1

  • CarboplatinDrug

    If the patients can't tolerate cisplatin, they will be treated with carboplatin (AUC 4.5mg/mL·min) IV day 1

  • GemcitabineDrug

    Gemcitabine ( 1000 mg/m2) IV days 1 and 8

What is being measured

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

  1. Objective Response Rate (ORR)

    The objective response rate is defined as the percentage of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1(RECIST v1.1) criteria. Per RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: From date of enrollment until disease progression,assessed up to 1 year

Secondary outcomes (3)

  1. Duration of Response (DoR)

    The duration of response (CR or PR) is defined as the earliest date a participant achieved a CR or a PR, calculated from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.

    Measured: From date of enrollment until disease progression,assessed up to 3 years

  2. Progression free survival (PFS)

    Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.

    Measured: From date of enrollment until the date of first documented progression,assessed up to 3 years

  3. Overall Survival (OS)

    Overall survival is defined as the time interval in days between the date of the first dose of study drug and the participant's death from any cause.

    Measured: From date of enrollment until death,assessed up to 5 years

Timeline

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

  1. First posted1 Sep 2021
  2. Study start1 Oct 2021 (estimated)
  3. Primary completion1 Sep 2023 (estimated)
  4. Study completion1 Sep 2024 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05030077
Sponsor's protocol ID
ALTER-UC-008
Status last verified
Aug 2021
First submitted
16 Aug 2021
Last updated
1 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib, Cisplatin and Carboplatin in people with Urothelial Carcinoma and Anlotinib, run by Tianjin Medical University Second Hospital 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 8 inclusion and 23 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 1 Sep 2021. 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 phase mean?

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 Hailong Hu, MD,PhD (0086-13662096232, Hhllove2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From date of enrollment until disease progression,assessed up to 1 year). 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 NCT05030077.

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 1 Sep 2021.

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