A Multicenter, Randomized, Open, Parallel Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2450 Injection Combined With Androtinib Hydrochloride Capsules Versus Paclitaxel as Weekly Treatment in the Treatment of Recurrent Platinum-resistant Ovarian Cancer

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.2 sites in 1 country405 target enrollmentSeptember 28, 2021

ConditionsRecurrent Platinum-resistant Ovarian Cancer

InterventionsAnlotinib Hydrochloride Capsules TQB2450 injection Paclitaxel injection

DrugsAnlotinib Hydrochloride Capsules Paclitaxel injection TQB2450 injection

Overview

Phase: Phase 3
Intervention: Anlotinib Hydrochloride Capsules
Conditions: Recurrent Platinum-resistant Ovarian Cancer
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 405
Locations: 2
Primary Endpoint: Disease progression-free survival(PFS) evaluated by Independent Review Committee(IRC)
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A clinical study to evaluate the efficacy and safety of TQB2450 injection combined with Anlotinib Hydrochloride capsules versus weekly treatment with paclitaxel of recurrent platinum-resistant ovarian cancer.A total of 405 subjects will be enrolled.

Registry

clinicaltrials.gov

Start Date

September 28, 2021

End Date

December 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subjects voluntarily joined the study, signed the informed consent form(ICF), and had good compliance;
•age: 18-75 years old (when signing ICF; Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) score 0-1; estimated survival time is more than 3 months;
•Epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathology or cytopathology;
•Subjects had disease recurrence or progression during prior chemotherapy with platinum-based regimens or within 6 months after the last dose of chemotherapy with platinum-based regimens (for at least 4 courses of treatment). Note: The definition of disease recurrence or progression needs to meet either of the following two items: a.Evidence of objective radiographic or clinical disease progression (for example, cytological reports of new ascites or pleural effusion); b.Persistent elevation of tumor marker CA125 (confirmed 1 week later) accompanied by clinical symptoms or physical examination indicating disease progression.
•The number of previous chemotherapy regimens does not exceed 4 lines, and it is required that no more than 1 systemic treatment regimen is accepted after platinum resistance;
•At least one measurable lesion was confirmed according toResponse Evaluation Criteria in Solid Tumors 1.1( RECIST 1.1) criteria;
•The function of main organs are well and meet the following standards: (1) Routine Blood routine examination standards (without blood transfusion or correction with hematopoietic stimulating factor drugs within 7 days before the examination ): a) Hemoglobin（HGB） ≥90 g/L; b) Absolute value of neutrophil（NEUT）≥1.5×109/L; c) Platelets count（PLT）≥ 80×109/L. (2) The biochemical examination shall meet the following standards: a) Total bilirubin (TBIL) ≤ 2 times the upper limit of normal (ULN) (Patients with Gilbert syndrome ≤ 3 × ULN); b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN. If it is accompanied by liver metastasis, ALT and AST≤5×ULN; c) Serum creatinine (CR) ≤ 1.5×ULN or Creatinine clearance (CCR) ≥60ml/min (Cockcroft-Gault glomerular filtration formula). d）Serum albumin (ALB) ≥30g/L (no albumin supplement within 7 days). (3) Blood coagulation function or thyroid function test should meet the following standards:
•a) Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR)≤1.5×ULN (no anticoagulant therapy); b) Thyroid Stimulating Hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be examined. If T3 and T4 levels are normal, it can be selected. (4) Heart color Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%.
•(5) Urine routine: urine protein \<2+ (when the baseline urine protein ≥ 2+, the patient will undergo a 24-hour urine protein quantitative test within 7 days, and can only be selected when urine protein \<1g);
•Women must meet one of the following conditions:

Exclusion Criteria

•Other malign combined diseases and medical history:
•Suffering from other non-epithelial ovarian tumors (for example, germ cell tumors, sex cord stromal tumors) or borderline ovarian epithelial tumors;
•Other malignant tumors appeared or were present within 3 years. The following two cases can be included: other malignant tumors treated by single operation have achieved 5-year DFS in a row; The cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
•There are Multiple factors affecting oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.);
•Unrelieved toxic reactions higher than CTCAE level 1 caused by any previous treatment, excluding hair loss;
•Received major surgical treatment, open biopsy, or suffered obvious traumatic injury within 28 days before the start of the study treatment;
•Long-term unhealed wounds or fractures;
•Arterial/venous thrombosis events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage and cerebral infarction), deep vein thrombosis and pulmonary embolism, etc; (Prophylactic use of anticoagulant therapy is allowed for patients with thrombotic tendency or undergoing anticoagulant therapy.)
•Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; i) Subjects with any severe and/or uncontrolled disease, including:
•After more than two kinds of drug treatment, blood pressure control is still not ideal (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg);

Arms & Interventions

TQB2450 injection + Anlotinib Hydrochloride capsules

TQB2450 injection: once every 21 days, 1200mg each time, intravenous infusion. The longest administration time should not exceed 24 months. Anlotinib Hydrochloride capsules: once a day, 12mg each time, oral administration on an empty stomach before breakfast for 2 weeks, withdrawal for 1 week, i.e. 3 weeks (21 days) as a course of treatment.

Intervention: Anlotinib Hydrochloride Capsules

TQB2450 injection + Anlotinib Hydrochloride capsules

Intervention: TQB2450 injection

Paclitaxel injection

80mg/m2, intravenous drip, once a week (D1, D8, D15 of 21 days), 21 days as a course of treatment.

Intervention: Paclitaxel injection

Outcomes

Primary Outcomes

Disease progression-free survival(PFS) evaluated by Independent Review Committee(IRC)

Time Frame: Baseline up to two years

The period from the first use of the drug to disease progression or death (whichever occurs first);

Overall survival (OS)

Time Frame: Baseline up to two years

The preriod from the first use of the drug to death from all causes. For subjects who are still alive at the last follow-up, the OS will be counted as data censored based on the last follow-up. For subjects who are lost follow-up, the OS will be counted as data cesored based on the last confirmed survival time before being lost to follow-up.

Secondary Outcomes

Objective response rate (ORR) evaluated by IRC and investigators(Baseline up to two years)
Disease Control Rate (DCR)(Baseline up to two years)
Duration of response (DOR)(Baseline up to two years)
Disease PFS evaluated by investigators(Baseline up to two years)
OS rate of 12 months(Baseline up to one year)
PFS rate of 6 months: including PFS rate of 6 months evaluated by IRC and investigators;(Baseline up to six months)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)，as well as abnormal laboratory examination indicators.(Baseline up to two years)