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Endometrial CarcinomaPhase 2NCT05121363

A Clinical Trial to Evaluate TQB2858 Injection Combined With Anlotinib Hydrochloride Capsule in the Treatment of Recurrent or Metastatic Advanced Endometrial Carcinoma

A Phase 2 study testing TQB2858 injection and Anlotinib Hydrochloride capsules in people with Endometrial Carcinoma, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 trial to evaluate TQB2858 injection combined with Anlotinib Hydrochloride capsule in the treatment of recurrent or metastatic advanced endometrial carcinoma Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Endometrial Carcinoma
What is being tested?
TQB2858 injection and Anlotinib Hydrochloride capsules
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
2 sitesChina
Study dates
Dec 2021to Jul 2023
Phase
Phase 2
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

  • Only those who meet all the following inclusion criteria can be enrolled in this study:
  • (1) The subjects voluntarily joined the study, signed the informed consent form;
  • (2) Age: 18 -75years old (when signing the informed consent); Performance status score: 0-1;The expected survival time is more than 3 months;
  • (3) Endometrial carcinoma confirmed by histopathology;
  • (4) Previous treatment with 1-2 line standard systemic chemotherapy regimen failed or intolerated;"intolerance" is defined as ≥ grade IV hematological toxicity or ≥ grade III non-hematological toxicity during treatment. Neoadjuvant or adjuvant chemotherapy is allowed in the early stage. If disease progression / recurrence occurs during neoadjuvant / adjuvant therapy or within 12 months after the end of treatment, neoadjuvant / adjuvant therapy is considered to be a first-line systemic chemotherapy failure for progressive diseases.
  • (5)Confirmed to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
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  • (6)The main organs function well and meet the following standards:
  • Blood routine examination standards (correction without blood transfusion and hematopoietic stimulating factor drugs within 14 days before examination): Hemoglobin (HGB) ≥ 80 g / L；The absolute value of neutrophils (NEUT) ≥ 1.5x109 / L；Platelet count ((PLT)) ≥ 90 × 109 PG / L.
  • Biochemical examination shall meet the following standards:Total bilirubin (TBIL) ≤ 1.5 times the normal upper limit (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN. If with liver metastasis, ALT and AST ≤ 5 × ULN;Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (Ccr) ≥ 60ml/min.
  • Blood coagulation function should meet the following standards: international standardized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy or over five drug half-lives );
  • Thyroid function examination should meet the following standards: the thyroid stimulating hormone (TSH) ≤ ULN; if abnormal, the levels of T3 and T4 should be examined. If the levels of T3 and T4 are normal, they can be selected.
  • Evaluation by color Doppler echocardiography: left ventricular ejection fraction ((LVEF)) ≥ 50%
  • (7) Female subjects of childbearing age should agree that contraceptive measures (such as IUDs or condoms) must be used during the study period and within 6 months after the end of the study; the serum pregnancy/urine pregnancy test is negative within 7 days before the study, and must be non-lactation subjects;male subjects should agree that contraceptive measures must be used during the study period and within 6 months after the end of the study

Who cannot join

  • Those who meet any of the following criteria will not be enrolled in this study:
  • (1) Concomitant disease and medical history:
  • Present or present with other malignant tumors within 2 years before medicine for the first time.The following two conditions can be included: other malignant tumors treated by single operation, disease-free survival (DFS) for 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (in situ) and T1 (tumor infiltrating basement membrane)]；
  • Pathological diagnosis of uterine sarcoma, such as carcinosarcoma (malignant mullerian mixed tumor), endometrial leiomyosarcoma, endometrial stromal sarcoma or other high-grade sarcomas；
  • There are a variety of factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.)
  • Unalleviated toxicity higher than Common Terminology Criteria for Adverse Events (CTCAE) level 1 due to any previous antineoplastic therapy, excluding alopecia and peripheral sensory nerve disorders;
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  • Major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment (excluding needle aspiration, endoscopic biopsy for diagnostic purposes, etc.);
  • A wound or fracture that has not been cured for a long time, possessing risk factors for fracture (such as bearing bone metastases, etc.)
  • Within 6 months before initial administration, there have been arteriovenous thrombotic events such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism,etc;
  • Those who have a history of psychotropic substance abuse and are unable to quit or have mental disorders;
  • Subjects with any severe and / or uncontrolled disease,including:
  • Blood pressure control is not satisfactory after standard treatment(systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg).
  • Patients who have experienced myocardial ischemia or myocardial infarction within six months; New York Heart Association(NYHA )grade ≥2 congestive heart failure; Grade ≥2 atrioventricular block; Arrhythmias that cannot be stably controlled with drugs (including corrected QT interva ≥470ms) and arrhythmias that may have a potential impact on trial treatment;
  • Active infection ( CTCAE grade ≥ 2 infection);
  • Decompensated liver cirrhosis, active hepatitis *;
  • active hepatitis (hepatitis B reference:Hepatitis B surface antigen( HBsAg )positive, and Hepatitis B virus DNA(HBV DNA)>2500 copies /mL or > 500 IU/mL; Hepatitis C reference: hepatitis C virus(HCV) antibody positive, and HCV virus titer test value exceeds the upper limit of normal value); Note: Subjects with positive surface antigen of hepatitis B or positive core antibody and hepatitis C patients eligible for inclusion are advised to continue antiviral therapy to prevent virus activation;
  • Active syphilis and active tuberculosis;
  • Renal failure requiring hemodialysis or peritoneal dialysis: glomerular filtration rate(eGFR) < 15ml/ (min•1.73㎡);
  • A history of immunodeficiency, including Human Immunodeficiency Virus( HIV) positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation;
  • Poor control of diabetes (Fasting blood glucose (FBG) > 10mmol/L, bedtime blood glucose > 11.1mmol/L and hemoglobin A1C (HbA1c) ≥8.5% before bedtime);
  • Patients with urine protein ≥++ as indicated by routine urine examination, and 24-hour urine protein quantity > 1.0g;
  • Persons suffering from epilepsy and requiring medical treatment.
  • (2) Tumor-related symptoms and treatment:
  • Received surgery, chemotherapy, radiation or other anticancer therapy within 4 weeks before the start of study treatment (the wash out period is calculated from the end of the last treatment); Those who had previously received local radiation therapy were eligible to enroll if they met the following criteria: the end of radiotherapy was more than 4 weeks before the start of study therapy (brain radiation was more than 2 weeks); The target lesions selected in this study are not in the radiotherapy region; or the target lesion is located in the radiotherapy area, but progression is confirmed.
  • Received the treatment of Chinese patent medicines with anti-tumor indications specified in the National Medical Products Administration(NMPA) approved drug instructions (including compound cantharidin capsules, Kangai injection, Kanglaite capsule/injection, Aidi injection, brucea javanica oil injection/capsule, Xiaoaiping tablet/injection, Huachansu capsule, etc.) within 2 weeks before the study treatment;
  • Previously received immunomodulator therapy, including therapeutic vaccines, cytokine therapy, or Anti-programmed death receptor 1(anti-PD-1), Programmed death ligand-1(PD-L1), Cytotoxic T lymphocyte-associated protein 4(CTLA-4), High purity recombinant protein（4-1BB）, T cell activation markers（OX-40） and other related immunotherapy drugs;
  • Previous use of anti-angiogenic drugs such as bevacizumab, anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, fruquintinib, etc.(applicable to the stage 2; stage 1: not include bevacizumab;
  • Received hormone therapy for endometrial cancer within 1 week prior to the first dose of trial drug (for endometrioid cancer only)
  • Pleural effusion, pericardial effusion, or ascites that uncontrolled and still requires repeated drainage (as determined by the investigator);
  • Imaging (CT or MRI) showed that the tumor had invaded the important blood vessels or was judged by the researchers to be most likely to invade the important blood vessels and cause fatal massive hemorrhage during the follow-up study.
  • Subjects with known central nervous system metastasis and / or cancerous meningitis; unless asymptomatic or treated and stable, no imaging evidence of new brain metastasis or enlarged brain metastasis was found at least 4 weeks after brain metastasis treatment, and steroid or anticonvulsant therapy was stopped for at least 14 days before the start of the study.
  • (3) Research treatment related:
  • Have a history of live attenuated vaccine administration within 28 days before the start of study treatment or planned live attenuated vaccine administration during the study period;
  • Have a history of severe allergy to Anlotinib Hydrochloride capsule or known components of TQB2858 injection;
  • An active autoimmune disease requiring systemic treatment (such as palliative drugs, corticosteroids, or immunosuppressants) occurred within 2 years before the start of study therapy. Alternative therapies (such as thyroxine, insulin, or physical corticosteroids for adrenal or pituitary dysfunction, etc.) are not considered systemic treatment;
  • Diagnosed as immunodeficient or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose >10mg/ d of prednisone or other equivalent hormone) and continued use within 2 weeks of initial administration;
  • (4) Participated in clinical trials of other antitumor drugs within 4 weeks before initial administration or no exceeding drug' 5 half-lives.
  • (5)According to the researcher'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 for other reasons.

Trial locations and contacts

2 sites in 1 country.

Beihua Kong, Doctor contact

18560081888

kongbeihua@sdu.edu.cn

China2 sites

  • Hunan Cancer Hospita

    Changsha, Hunan, 410013

    Jing Wang, Doctor, 13875902083, wangjing0081@126.com

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Beihua Kong, Doctor, 18560081888, kongbeihua@sdu.edu.cn

Other trials in China

About this study

Official title: A Single-arm, Multicenter Phase II Clinical Trial to Evaluate TQB2858 Injection Combined With Anlotinib Hydrochloride Capsule in the Treatment of Recurrent or Metastatic Advanced Endometrial Cancer

A clinical trial to evaluate TQB2858 injection combined with Anlotinib Hydrochloride capsule in the treatment of recurrent or metastatic advanced endometrial carcinoma

Being tested
TQB2858 injection, Anlotinib Hydrochloride capsules
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • TQB2858 injectionDrug

    TQB2858 is an anti-programmed death receptor 1(anti-PD-1) /Transforming growth factor-β(TGF-β )bi-functional fusion protein

  • Anlotinib Hydrochloride capsulesDrug

    Anlotinib Hydrochloride is a multi-target tyrosine kinase inhibitor.

Study groups in NCT05121363
Study groupRoleWhat they receive
TQB2858 injection + Anlotinib Hydrochloride capsulesExperimentalTQB2858 injection: once every 3 weeks, 1800mg each time, intravenous infusion. Until the disease progression or unbearable adverse events occur. Anlotinib Hydrochloride capsules: once a day,12mg each time, oral administration before breakfast. Continuous administration for 2 weeks, withdrawal for 1 week, i.e. 3 weeks (21 days) as a course of treatment. Until the disease progression or unbearable adverse events occur.
Receives: Drug: TQB2858 injection; Drug: Anlotinib Hydrochloride capsules

What is being measured

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

  1. Objective response rate (ORR)

    Proportion of patients whose tumors shrank by a certain amount and remained for a certain period of time, including complete response (CR) and partial response (PR) cases

    Measured: Baseline up to two years

Secondary outcomes (5)

  1. Progress Free Survival (PFS)

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

    Measured: Baseline up to two years

  2. 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

  3. 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

  4. Overall Survival (OS)

    The period 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 censored based on the last confirmed survival time before being lost to follow-up.

    Measured: Baseline up to two years

  5. Incidence of adverse events: Occurrence of all adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)

    AEs refer to all adverse medical events that occur after a patient or clinical trial subject receives an experimental drug, which can be expressed as symptoms, signs, diseases, or abnormalities in laboratory tests, but are not necessarily related to the treatment of the experimental drug. SAEs refer to adverse medical conditions such as death, life threatening, permanent or severe disability, loss of function, the need for hospitalization or prolonged hospitalization , and congenital abnormalities or birth defects after the subject receives the experimental drug

    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 posted16 Nov 2021
  2. Study startDec 2021 (estimated)
  3. Primary completionMay 2023 (estimated)
  4. Study completionJul 2023 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
113 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05121363
Sponsor's protocol ID
TQB2858-II-01
Status last verified
Nov 2021
First submitted
15 Nov 2021
Last updated
30 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQB2858 injection and Anlotinib Hydrochloride capsules in people with Endometrial Carcinoma, 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 13 inclusion and 38 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 30 Nov 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Beihua Kong, Doctor (18560081888, kongbeihua@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Baseline up to two years). 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 NCT05121363.

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 30 Nov 2021.

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