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

NCT05030077 | Unknown Phase 2

• 1 other identifier: ALTER-UC-008
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urothelial Carcinoma; Anlotinib; Urogenital Neoplasms; Cisplatin; Carboplatin; Gemcitabine; Antineoplastic Agents

Keywords

Urothelial Carcinoma; Chemotherapy; Anlotinib

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

• Duration of Response (DoR)

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

• Progression free survival (PFS)

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

• Overall Survival (OS)

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

Interventions

Anlotinib DRUG

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

Also known as: AL3818

Cisplatin DRUG

Cisplatin (70 mg/m2) IV day 1

Carboplatin DRUG

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

Gemcitabine DRUG

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical Unversity Second Hospital

Tianjin, 300211, China

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urogenital Neoplasms

Interventions

anlotinib; Cisplatin; Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yuanjie Niu, MD,PhD

  Tianjin Medical Unversity Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hailong Hu, MD,PhD

CONTACT

0086-13662096232; Hhllove2004@163.com

Yuanjie Niu, MD,PhD

CONTACT

0086-13821827881; niuyuanjie9317@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: September 1, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

CN (1)