A Single-arm, Single-center Phase II Clinical Study on the Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection Combined With Fruquintinib Capsules in the Second-line Treatment of Patients With Advanced Gastric Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

This study is a single-arm, open, phase II clinical trial aimed at evaluating the anti-tumor efficacy and safety of paclitaxel polymeric micelles for injection combined with furquintinib as second-line treatment for advanced gastric cancer.

Eligibility criteria

Qualifiers

Blood routine: leucocyte ≥3.0×109/L, absolute neutrophil count (ANC)≥1.5 ×109/L, platelet count(PLT)≥ 100×109/L, Hemoglobin ( Hb )≥ 9.0 g/dL;

Liver function : total bilirubin ≤ 1.5 ×ULN;Alanine aminotransferase(ALT)/aspartate aminotransferase (AST)≤2.5×ULN without liver metastasis ;ALT/AST ≤ 5 ×ULN with liver metastasis;

Coagulation function : international normalized ratio (INR)≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN ;(Investigator judge that INR and APTT should be in the safe and effective treatment range for patients who are undergoing anticoagulant therapy);

Renal function : serum creatinine ≤ 1.5×ULN ;

Disqualifiers

1. Patients have received clinical trials of other research drugs or research instruments within 28 days before the first study of treatment ;or received anti-tumor treatment including but not limited chemotherapy, radiotherapy (excluding palliative radiotherapy completed at least 1 week before the treatment )and targeted therapy within 2 weeks before the first study of treatment; 2.The toxicity of previous anti-tumor therapy has not returned to the level of 0 or 1 (excluding alopecia , peripheral neurotoxicity caused by chemotherapy ≤ 2) ; 3.Surgery was performed within 4 weeks before the first treatment (except biopsy) or the surgical incision was not completely healed ; 4. There were ascites requiring drainage or diuretic treatment, or pleural effusion or pericardial effusion requiring drainage or accompanied by shortness of breath within 2 weeks before the first treatment; 5.Symptomatic brain metastasis or spinal cord compression(except for previously treated patients with brain metastases, if the clinical condition was stable within 4 weeks before the first treatment and the imaging evidence did not show disease progression).

Trial design

Treatments tested in this trial

  • Paclitaxel Polymeric Micelles for Injection combined with Fruquintinib Capsules

Treatment groups

21 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators