A Clinical Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsules Versus Paclitaxel as Weekly Treatment of Relapsed Platinum-resistant Ovarian Cancer

NCT05145218 | Unknown Phase 3

• 1 other identifier: TQB2450-III-10
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 2

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.

Conditions

Recurrent Platinum-resistant Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

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

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

  Baseline up to two years

• Overall survival (OS)

  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.

  Baseline up to two years

Secondary Outcomes (7)

• Disease PFS evaluated by investigators

  Baseline up to two years

• PFS rate of 6 months: including PFS rate of 6 months evaluated by IRC and investigators;

  Baseline up to six months

• Objective response rate (ORR) evaluated by IRC and investigators

  Baseline up to two years

• Duration of response (DOR)

  Baseline up to two years

• Disease Control Rate (DCR)

  Baseline up to two years

Study Arms (2)

TQB2450 injection + Anlotinib Hydrochloride capsules

EXPERIMENTAL

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.

Drug: Anlotinib Hydrochloride Capsules; Drug: TQB2450 injection

Paclitaxel injection

ACTIVE COMPARATOR

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

Drug: Paclitaxel injection

Interventions

Anlotinib Hydrochloride Capsules DRUG

Anlotinib Hydrochloride is a multi-target tyrosine kinase inhibitor.

TQB2450 injection + Anlotinib Hydrochloride capsules

Paclitaxel injection DRUG

Paclitaxel is a novel anti-microtubule agent.

Paclitaxel injection

TQB2450 injection DRUG

TQB2450 is a programmed cell death protein 1 (PD-1) humanized monoclonal antibody.

TQB2450 injection + Anlotinib Hydrochloride capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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:
• Surgical sterilization has been performed;
• For those who have been menopausal, the menopause has been stopped for at least 1 year; (3) Women with fertility must meet the following conditions: The serum pregnancy test before the first administration is negative and must be non-lactating subjects;During the entire study period, agree to use an approved method of contraception (for example: oral contraception, injection contraception or implanted, barrier contraception, spermicides and condoms, Intrauterine devices), and the method of contraception remained unchanged throughout the study period.

You may not qualify if:

• \) 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);
• Patients with grade ≥ 2 myocardial ischemia or myocardial infarction, arrhythmia (including corrected QT interval (QTc) ≥ 450ms (male) and QTc ≥ 470ms (female) and grade ≥ 2 congestive heart failure (New York Heart Association (NYHA) classification);
• Active or uncontrolled severe infection (≥ CTCAE grade 2 infection);
• Abnormal liver\*:
• Patients with renal failure requiring hemodialysis or peritoneal dialysis;
• Patients with a history of immunodeficiency, including Human Immunodeficiency Virus (HIV) positive or other acquired or congenital immunodeficiency disease, or with a history of organ transplantation;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510100, China

RECRUITING

AnYang Tumor Hospital

Anyang, Henan, 455000, China

RECRUITING

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Xin Huang, Doctor

CONTACT

13925043663; huangxin@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 6, 2021
• Study Start: September 28, 2021
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 8, 2021

Record last verified: 2021-12

Locations

CN (2)