Combining TAS-102 and Anlotinib for advanced gastric cancer treatment

TAS-102 Combined With Anlotinib in Patients With Metastatic Gastric Cancer Refractory to Standard Treatments (THALIA): a Prospective Single-arm Phase II Study

This study is testing if combining two medications, TAS-102 and Anlotinib, can help people with advanced gastric cancer who haven't had success with other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy, radiation, Anlotinib
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05029102 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of TAS-102 and Anlotinib in patients with metastatic gastric cancer who have previously undergone at least two lines of standard chemotherapy. The study aims to determine how well these two medications work together in this patient population. Participants must be between 18 and 75 years old and meet specific health criteria to ensure their safety during the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed metastatic gastric cancer who have progressed after at least two lines of prior chemotherapy.

Not a fit: Patients with active bleeding, recent thrombosis, or those who do not meet the health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with advanced gastric cancer who have limited treatment alternatives.

How similar studies have performed: While there have been studies exploring similar treatment combinations, the specific pairing of TAS-102 and Anlotinib in this context is relatively novel.

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.

Where this trial is running

Hangzhou, Zhejiang

• First affiliated hospital, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Weijia Fang, MD.

Conditions Gastric Cancer