TAS-102 and Anlotinib in ≥3 Lines mGC

NCT ID: NCT05029102

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAS-102 and Anlotinib

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

Group Type: EXPERIMENTAL

TAS 102

Intervention Type: DRUG

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

Anlotinib

Intervention Type: DRUG

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

Interventions

TAS 102

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

Intervention Type: DRUG

Anlotinib

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• According to the judgment of the researcher, the patient may have other factors that may affect the results of the study or cause the study to be terminated, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment. Patients have severe laboratory abnormalities, which will affect the safety of the patient.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Weijia Fang, MD

Director of Medical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weijia Fang, MD.

Role: CONTACT

weijiafang@zju.edu.cn

+86-571-87235147

Facility Contacts

Weijia Fang, MD

Role: primary

weijiafang@zju.edu.cn

+86-571-87235147

References

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.

Reference Type: DERIVED

PMID: 39510786 (View on PubMed)

Other Identifiers

THALIA

Identifier Type: -

Identifier Source: org_study_id