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Recurrent Platinum-resistant Ovarian CancerPhase 3NCT05145218

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

A Phase 3 study testing Anlotinib Hydrochloride Capsules, Paclitaxel injection and TQB2450 injection in people with Recurrent Platinum-resistant Ovarian Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Anlotinib Hydrochloride Capsules, Paclitaxel injection and TQB2450 injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
405 participants
Where
2 sitesChina
Study dates
28 Sep 2021to Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) The subjects voluntarily joined the study, signed the informed consent form(ICF), and had good compliance;
  • 2) 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;
  • 3) Epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathology or cytopathology;
  • 4) 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.
  • 5) 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;
  • 6) At least one measurable lesion was confirmed according toResponse Evaluation Criteria in Solid Tumors 1.1( RECIST 1.1) criteria;
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  • 7) 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:
  • 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%.
  • 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);
  • 8) 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.

Who cannot join

  • 1) 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;
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  • 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*:
  • Hepatitis B virus infection, HBsAg positive, HBV DNA positive or copy number exceeds the upper limit of normal value in the research center; Remarks: Continuous antiviral therapy (nucleoside analogues are recommended) and monitoring of HBV DNA every 3 to 6 months are recommended for HBsAg positive patients eligible for inclusion，HBcAb positive subjects but _HBsAg negative subjects can be monitored for HBV DNA every 3 to 6 months, and antiviral therapy is required if the virus is activated.
  • Hepatitis C virus infection, HCV antibody positive, HCV RNA positive or the test value exceeds the upper limit of the normal value of the research center; Remarks: Patients with HCV who are eligible for inclusion also need continuous antiviral therapy to prevent viral activation and can be monitored for HCV RNA every 3-6 months. If the virus is activated, direct antiviral therapy without interferon is recommended.
  • 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;
  • Previous or existing interstitial pneumonia, (non-infectious) pneumonia that requires adrenal corticosteroid therapy, currently suffering from other types of pneumonia ≥ 2, or lung function tests confirmed severely impaired lung function (Forced Expiratory Volume in the first second (FEV1) or diffusing capacity of lung for carbon monoxide ( DLCO) or DLCO per alveolar volume (DLCO /VA) accounts for the expected value %<40%) and other objective evidence;
  • Poor control of diabetes (Fasting Blood Glucose (FBG) > 10mmol/L);
  • Patients suffering from epilepsy and requiring medical treatment;
  • 2) Tumor-related symptoms and treatment:
  • Patients who had received surgery, chemotherapy, radiotherapy, hormone therapy, biotherapy, and immunotherapy within 4 weeks before the start of the study treatment (the washout period was calculated from the end of the last treatment); Patients who had previously received local radiotherapy could be included if they met the following conditions: The end of radiotherapy was more than 4 weeks after the start of study therapy (brain radiotherapy was more than 2 weeks); And the target lesions selected in this study are not in the radiotherapy area; Or the target lesion is located in the radiotherapy area, but progression is confirmed.
  • Received the treatment of proprietary Chinese medicines with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks before the start of the study treatment (Including compound cantharidin capsules, Kangai injection, Kanglaite capsule/injection, Aidi injection, brucea javanica oil injection/capsule, Xiaoaiping tablet/injection, Huachansu capsule, etc.);
  • Previously received related immunotherapy drugs for programmed death-1 (PD-1), programmed death-Ligand 1 (PD-L1), cytolytic T lymphocyte-associated antigen-4 (CTLA-4) or similar Tyrosine Kinase Inhibitor (TKI) small molecule anti-angiogenesis drugs such as Androtinib Hydrochloride;
  • Imaging (CT or MRI) shows that the tumor has invaded the periphery of important blood vessels or the investigator judges that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the subsequent study;
  • Patients with clinical symptoms of pleural effusion, pericardial effusion or ascites requiring Repeated puncture or drainage or those who have received drainage for the purpose of treatment within 1 month before randomization;
  • Subjects with known Central Nervous System (CNS) metastasis and/or cancerous meningitis; Unless asymptomatic, or treated and stable, no radiographic evidence of new or enlarged brain metastases was found for at least 4 weeks after brain metastases treatment, and steroid or anticonvulsant therapy was discontinued for at least 14 days before study treatment began.
  • 3) Study treatment related:
  • Live attenuated vaccine vaccination history within 28 days before the start of the study treatment or planned live attenuated vaccination during the study period;
  • Patients with a history of severe allergic disease and severe drug allergy.It is known to be allergic to any component prescribed in paclitaxel or TQB2450 injection or Anlotinib hydrochloride capsules prescription;
  • Active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, corticosteroid or immunosuppressant) occurred within 2 years before the start of the study treatment. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroid for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy;
  • Patients who have been diagnosed with immunodeficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (Dose>10mg/day prednisone or other curative hormones) and are still continuing to use them within 2 weeks of first administration; 4) Participated in other anti-tumor drug clinical trials within 4 weeks before grouping; 5) According to the investigator's judgment, subjects who have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or who are considered unsuitable for inclusion in the group for other reasons.

Trial locations and contacts

2 sites in 1 country.

Xin Huang, Doctor contact

13925043663

huangxin@sysucc.org.cn

China2 sites, 2 recruiting

  • AnYang Tumor Hospital

    Anyang, Henan, 455000

    LiHong Lin, master, 13903721559, anyanglinlihong@163.com

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510100

    Xin Huang, Doctor, 13925043663, huangxin@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Being tested
Anlotinib Hydrochloride Capsules, Paclitaxel injection, TQB2450 injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anlotinib Hydrochloride CapsulesDrug

    Anlotinib Hydrochloride is a multi-target tyrosine kinase inhibitor.

  • Paclitaxel injectionDrug

    Paclitaxel is a novel anti-microtubule agent.

  • TQB2450 injectionDrug

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

Study groups in NCT05145218
Study groupRoleWhat they receive
TQB2450 injection + Anlotinib Hydrochloride capsulesExperimentalTQB2450 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.
Receives: Drug: Anlotinib Hydrochloride Capsules; Drug: TQB2450 injection
Paclitaxel injectionActive comparator80mg/m2, intravenous drip, once a week (D1, D8, D15 of 21 days), 21 days as a course of treatment.
Receives: Drug: Paclitaxel injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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);

    Measured: Baseline up to two years

  2. 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.

    Measured: Baseline up to two years

Secondary outcomes (7)

  1. Disease PFS evaluated by investigators

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

    Measured: Baseline up to two years

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

    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) .

    Measured: Baseline up to six months

  3. Objective response rate (ORR) evaluated by IRC and investigators

    , 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.

    Measured: Baseline up to two years

  4. Duration of response (DOR)

    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) .

    Measured: Baseline up to two years

  5. Disease Control Rate (DCR)

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

    Measured: Baseline up to two years

  6. OS rate of 12 months

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

    Measured: Baseline up to one year

  7. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)，as well as abnormal laboratory examination indicators.

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

    Measured: Baseline up to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2021
  2. Study start28 Sep 2021
  3. Primary completionOct 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
405 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05145218
Sponsor's protocol ID
TQB2450-III-10
Status last verified
Dec 2021
First submitted
23 Nov 2021
Last updated
8 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anlotinib Hydrochloride Capsules, Paclitaxel injection and TQB2450 injection in people with Recurrent Platinum-resistant Ovarian Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xin Huang, Doctor (13925043663, huangxin@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease progression-free survival(PFS) evaluated by Independent Review Committee(IRC) (time frame: Baseline up to two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05145218.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.

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