Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer

Study Overview
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Brief Summary
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Multicenter, prospective, randomized studies.Evaluation of the sensitivity to different chemotherapy regimens in platinum-partial sensitive recurrent ovarian cancer based on 11 gene tests of homologous recombination pathway.

Detailed Description
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Patients meeting the following inclusion criteria were randomly divided into two groups in a 1:1 ratio: paclitaxel/platinum chemotherapy group (TP) and Doxorubicin Hydrochloride Liposome Injection/platinum chemotherapy group (PP) (the specific chemotherapy regimens are as follows.Chemotherapy to tumor progression or adverse reactions can not be tolerated, effective chemotherapy patients with a maximum of 6 cycles of chemotherapy.The primary endpoint was progression-free survival (PFS), and the secondary endpoints were safety and overall survival.Also USES the next-generation sequencing (NGS) method to detect patients with recurrence after tumor tissues (including chest, ascites, homologous recombination pathway in the tumor tissue and peripheral blood ctDNA 11 genetic mutations, rearrangement, and so on and so forth, whether patients with analysing the homologous recombination pathways for paclitaxel/platinum chemotherapy or Doxorubicin Hydrochloride Liposome Injection/platinum chemotherapy has different sensitivity.

Official Title
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Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer Based on 11 Gene Tests of Homologous Recombination Pathway

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Doxorubicin Hydrochloride Liposome Injection+carboplatin
* Drug: paclitaxel +carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 18-75 years old PS score: ECOG 0   2 histopathologically confirmed primary high-grade serous adenocarcinoma or high-grade endometrioid adenocarcinoma of the ovary, fallopian tube or peritoneum; the time interval between this recurrence and the last chemotherapy was 6-12 months; evaluate the ability of bone marrow, liver, kidney, heart and other important organ functions to withstand chemotherapy; expected survival over 3 months; sign the informed consent. Exclusion Criteria: brain metastasis or the presence of symptoms caused by brain metastasis; serious complications; acute inflammatory reaction; other tumors; a history of allergy to paclitaxel or polyropyridone liposomes;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PP<br>Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, day 1, intravenous drip, repeated every three weeks. | Drug: Doxorubicin Hydrochloride Liposome Injection+carboplatin<br>* Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, first day, intravenous drip, repeated every three weeks.<br>* Other names: PP;|
| Active Comparator: TP<br>paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks. | Drug: paclitaxel +carboplatin<br>* paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.<br>* Other names: TP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS（Progression-Free-Survival) | From the date of randomization to the time of tumor progression | up to 24months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS(Overall survival) | Time from random day to death (month) | up to 36months | 
| ORR( Objective response rate) | the percentage of patients whose tumors shrink a certain amount and stay that way for a certain amount of time | up to 12 months |