TAS-102 and Anlotinib in ≥3 Lines mGC

NCT05029102 | Recruiting Phase 2

• 1 other identifier: THALIA
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy and safety of TAS-102 and Anlotinib in patients with metastatic gastric cancer who had been treated with ≥ 2 lines of prior standard chemotherapy

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  The time elapsed between treatment initiation and tumor progression

  4 months

Secondary Outcomes (2)

• Overall Response Rate

  2 months

• Overall Survival

  9 months

Study Arms (1)

TAS-102 and Anlotinib

EXPERIMENTAL

TAS-102: 35 mg/m2，per oral，twice daily, days 1-5 and 8-12 of each 28-day cycle Anlotinib: 10mg，per oral，once daily，days 1-14 of each 21-day cycle

Drug: TAS 102; Drug: Anlotinib

Interventions

TAS 102 DRUG

35 mg/m2，per oral，twice daily, days 1-5 and 8-12 of each 28-day cycle

TAS-102 and Anlotinib

Anlotinib DRUG

10mg，per oral，once daily，days 1-14 of each 21-day cycle

TAS-102 and Anlotinib

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years, ≤75 years
• Histologically confirmed gastric cancer with distant metastasis
• ECOG 0-1
• Progression on ≥ 2 lines of prior standard chemotherapy
• Patients can swallow pills normally
• Expected overall survival ≥6 months
• Blood routine: no blood transfusion or blood products usage within 14 days, G-CSF or other hematopoietic stimulator was not used. WBC counts \> 3000/µl，Absolute neutrophil count (ANC) ≥ 1500 cells/µl，Platelet count ≥ 100,000/µl，Hemoglobin ≥ 9.0 g/dL.
• AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine\<ULN
• Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN
• Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment;
• Informed consent has been signed.

You may not qualify if:

• Active bleeding within 3 months; Occurrence of arterial/venous thrombosis within 6 months; Hereditary or acquired bleeding (e.g., clotting dysfunction) or thrombotic tendencies; Full dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes are currently being used or have been used recently (10 days prior to the commencement of study treatment); Surgery (except for biopsy) was performed within 4 weeks prior to the study or the surgical incision was not fully healed; Aspirin (\> 325 mg/ day) or dipyridamole, ticlopidine, clopidogrel, and silotazole are currently being used or have recently been used (10 days prior to the study).
• Certain or suspected brain metastases.
• Patients who have received prior therapy of any study drug;
• Serious uncontrolled systemic diseases, such as severe active infections;
• A person is known to be infected with the immunodeficiency virus (HIV) or known to be HIV-positive;
• Patients have suffered from other malignancies in the past 5 years except cervical carcinoma in situ or basal cell carcinoma of the skin
• Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA \>500 IU/mL) or active HCV carriers with HCV RNA can be detected. Remarks: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA \< 500 IU/mL) may be enrolled
• Anti-infective therapy was not discontinued 14 days before the study;
• A prior history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia, and symptomatic interstitial lung disease or the presence of active pneumonia on a chest CT scan within 4 weeks prior to the study.
• Patients have a history of intestinal obstruction within six months. Patients with incomplete obstruction syndrome of ileus at the time of initial diagnosis may be enrolled in the study if they have received definitive (surgical) treatment to resolve the symptoms, as assessed by the investigator.
• Patients have high blood pressure that cannot be well controlled by antihypertensive medication (systolic ≥140 mmHg or diastolic ≥90 mmHg)
• Urine routine indicated urinary protein ≥++ and confirmed 24-hour urinary protein \>1.0g;
• Known to be allergic to any study drug;
• Patients have participated in other drug clinical studies within 4 weeks before enrollment;
• Lactating women

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (1)

• Ying T, Xia R, Zhang Y, Dai J, Wang Y, Xie X. Cost-effectiveness analysis of trifluridine/tipiracil in the treatment of heavily pretreated metastatic gastric cancer from the perspective of Chinese healthcare system. BMJ Open. 2024 Nov 7;14(11):e080846. doi: 10.1136/bmjopen-2023-080846.

  PMID: 39510786 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

trifluridine tipiracil drug combination; anlotinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Weijia Fang, MD.

CONTACT

+86-571-87235147; weijiafang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Medical Oncology

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: August 31, 2021
• Study Start: September 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)