Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Recurrence

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Antibodies

Antibodies, Monoclonal

Paclitaxel

Albumin-Bound Paclitaxel

Immunoglobulins

Tyrosine Kinase Inhibitors

Tubulin Modulators

Antimitotic Agents

Tyrosine

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.

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

Anlotinib Hydrochloride is a multi-target tyrosine kinase inhibitor.

Anlotinib Hydrochloride Capsules

Paclitaxel is a novel anti-microtubule agent.

Paclitaxel injection

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

TQB2450 injection

Xin Huang, Doctor

LiHong Lin, master

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.

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

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

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

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.

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

The proportion of subjects reaching 6 months from firstly- recorded objective tumor response (complete remission(CR) or partial remission(PR)) to firstly-recorded objective tumor progression or death due to any cause (whichever occurred first) .

, the proportion of subjects whose tumors are evaluated as complete remission(CR) and partial remission(PR) by IRC and investigators. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment.

The period from firstly-recorded objective tumor response (CR or PR) to firstly-recorded objective tumor progression or death due to any cause (whichever occurs first) .

Proportion of subjects whose tumors shrink or remain stable for a certain period, including complete remission（CR）, partial remission（PR） and stable disease（SD）;

The proportion of subjects who survive for 12 months after the first dose

The proportion of AEs and SAEs recorded afte signing the informed consent form(ICF).

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial