A Single-arm, Phase II Trial of Hetrombopag for the Treatment of Concurrent Chemoradiotherapy-induced Thrombocytopenia in Patients With Advanced Solid Tumors
Thrombocytopenia represents one of the main toxicities of concurrent chemoradiotherapy, which may necessitate chemotherapy dose reductions, dose delays, or discontinuation, and even compromise survival. Hetrombopag, a thrombopoietin receptor agonist, has shown efficacy and safety in patients with chemotherapy-induced thrombocytopenia. However, the efficacy of hetrombopag in patients who received concurrent chemoradiotherapy is not clear yet. This study aimed to evaluate the efficacy and safety of hetrombopag in this patient population.
• Age ≥ 18 years old, regardless of gender;
• Malignant tumor patients diagnosed through pathological or cytological examination, regardless of cancer type, may experience thrombocytopenia during radical synchronous radiotherapy and chemotherapy treatment;
• Platelet count of patients ≤ 75 × 10\^9/L on the day or 3 days prior to enrollment;
• Expected survival time ≥ 12 weeks;
• ECOG PS score for physical condition: 0-2 points;
• The laboratory inspection indicators meet the following requirements:
‣ Renal function: Cr ≤ ULN (upper limit of normal value) x 1.5, endogenous creatinine clearance rate (Ccr) ≥ 55 ml/min;
⁃ Liver function: Total bilirubin ≤ ULN × 1.5; ALT and AST ≤ ULN × 3; (If it is intrahepatic cholangiocarcinoma or liver metastasis, total bilirubin should not exceed 3 times the normal upper limit, and transaminase should not exceed 5 times the normal upper limit);
• Women of childbearing age agree to use contraception during the study period and within 6 months after the end of the study; And not a lactating patient; Male patients who agree to contraception during the study period and within 6 months after the end of the study;
• Those who have not participated in clinical trials of other drugs within the 4 weeks prior to enrollment;
• It is expected that those with good compliance will be able to follow up on therapeutic effects and adverse reactions according to the protocol requirements;
• No serious complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal disorders Obstruction, non cancerous fever\>38 °C;
• The subjects are able to understand the situation of this study and voluntarily sign an informed consent form.