Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433830
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-04-29
Brief Title:
Hetrombopag for the Thrombocytopenia Induced by Concurrent Chemoradiotherapy
Sponsor:
Sir Run Run Shaw Hospital
Organization:
Sir Run Run Shaw Hospital
Study Overview
Official Title:
A Single-arm Phase II Trial of Hetrombopag for the Treatment of Concurrent Chemoradiotherapy-induced Thrombocytopenia in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Antitumor related therapy is one of the common causes of thrombocytopenia Chemotherapy regimens based on drugs such as gemcitabine platinum anthracycline and paclitaxel are high-risk options for thrombocytopenia The degree of thrombocytopenia caused by external radiation therapy mainly depends on the irradiation dose irradiation site irradiation field size and irradiation duration The synchronous radiotherapy and chemotherapy regimen for head and neck tumors esophageal cancer rectal cancer and other cancers often involves platinum drugs and the irradiation site often involves flat and irregular bones Therefore the incidence of thrombocytopenia in patients during the treatment process is higher than that of chemotherapy or radiotherapy alone In a phase III clinical study on the combination of carboplatin and paclitaxel in the treatment of esophageal cancer the incidence of thrombocytopenia was as high as 54 Once thrombocytopenia occurs it may lead to a decrease in chemotherapy drug dosage delay and cessation of radiotherapy and chemotherapy and may require platelet infusion In follow-up studies of various cancer patients it has been found that reducing the dosage of chemotherapy drugs or delaying the chemotherapy cycle will reduce treatment efficacy and lead to poor prognosis including shortened disease-free survival DFS and overall survival OS time
TPO-RA drugs are currently approved for indications in the fields of chronic primary immune thrombocytopenia ITP severe aplastic anemia SAA and chronic liver disease CLD There are also relevant data reports in the CIT field A phase II clinical study using romiplostim for the treatment of CIT enrolled a total of 60 patients After treatment with romiplostim 85 of patients returned to normal platelet count within 3 weeks and resumed chemotherapy In the subsequent prescribed chemotherapy cycle only 68 of patients experienced a relapse due to another round of chemotherapy The occurrence of CIT leads to a decrease or delay in chemotherapy dose In another randomized placebo-controlled phase II study using eltrombopag for the prevention of solid tumor CIT patients received gemcitabine monotherapy or gemcitabine combined with cisplatincarboplatin regimen chemotherapy and treated with eltrombopag or placebo 100mg before and 5 days after chemotherapy In the 1-6 chemotherapy cycles the average platelet count on the day before chemotherapy in the eltrombopag group was numerically higher than that in the placebo group but did not reach statistically significant differences The incidence of grade 34 thrombocytopenia in the eltrombopag group was lower than that in the placebo group Among patients in the combination chemotherapy group the average time required for eltrombopag group to recover from the lowest platelet count to normal was 8 days The placebo group on the other hand requires 15 days and the incidence of delayedreduced chemotherapy dose or dose loss due to thrombocytopenia is lower in patients in the eltrombopag group Therefore in gemcitabine based chemotherapy treatment with eltrombopag can shorten the time for platelet minimum recovery and reduce the delayedreduced chemotherapy dose caused by thrombocytopenia However there is still a lack of stronger evidence-based medicine for the application of TPO-RA drugs in CIT and there is no relevant data in the field of concurrent chemoradiotherapy induced thrombocytopenia
TPO-RA drugs are currently approved for indications in the fields of chronic primary immune thrombocytopenia ITP severe aplastic anemia SAA and chronic liver disease CLD There are also relevant data reports in the CIT field A phase II clinical study using romiplostim for the treatment of CIT enrolled a total of 60 patients After treatment with romiplostim 85 of patients returned to normal platelet count within 3 weeks and resumed chemotherapy In the subsequent prescribed chemotherapy cycle only 68 of patients experienced a relapse due to another round of chemotherapy The occurrence of CIT leads to a decrease or delay in chemotherapy dose In another randomized placebo-controlled phase II study using eltrombopag for the prevention of solid tumor CIT patients received gemcitabine monotherapy or gemcitabine combined with cisplatincarboplatin regimen chemotherapy and treated with eltrombopag or placebo 100mg before and 5 days after chemotherapy In the 1-6 chemotherapy cycles the average platelet count on the day before chemotherapy in the eltrombopag group was numerically higher than that in the placebo group but did not reach statistically significant differences The incidence of grade 34 thrombocytopenia in the eltrombopag group was lower than that in the placebo group Among patients in the combination chemotherapy group the average time required for eltrombopag group to recover from the lowest platelet count to normal was 8 days The placebo group on the other hand requires 15 days and the incidence of delayedreduced chemotherapy dose or dose loss due to thrombocytopenia is lower in patients in the eltrombopag group Therefore in gemcitabine based chemotherapy treatment with eltrombopag can shorten the time for platelet minimum recovery and reduce the delayedreduced chemotherapy dose caused by thrombocytopenia However there is still a lack of stronger evidence-based medicine for the application of TPO-RA drugs in CIT and there is no relevant data in the field of concurrent chemoradiotherapy induced thrombocytopenia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None