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Advanced Endometrial CancerPhase 2NCT05481645

Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.

A Phase 2 study testing TQB2450 injection, Anlotinib Hydrochloride Capsule and Carboplatin Injection in people with Advanced Endometrial Cancer and Sarcoma of Uterus, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 11 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This clinical study plans to enroll 69 endometrial cancer patients and 5-10 uterine sarcoma patients. The trial is divided into a lead-in phase and a main phase. The lead-in phase will include 9 subjects, while the main phase will enroll 60 endometrial cancer patients randomized 1:1. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
TQB2450 injection, Anlotinib Hydrochloride Capsule and Carboplatin Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
11 sitesChina
Study dates
26 Aug 2022to 30 Nov 2025
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects voluntarily participated in this study, signed the informed consent, and had good compliance;
  • Age: ≥18 years old (when signing the informed consent form); ECOG PS score: 0-1; expected survival period of more than 3 months; body mass index (BMI) > 18.5 and weight > 40kg;
  • Who have not received first-line systemic anticancer therapy and are not suitable for receiving treatment other than systemic treatment:
  • Group 1 and 2: Stage III/IV epithelial endometrial cancer (including endometrioid carcinoma, non-endometrioid carcinoma, carcinosarcoma) confirmed by histopathology, and the subject also needs to meet one of the following categories:
  • Newly diagnosed subjects: there are still residual lesions visible on imaging after non-radical surgery;
  • Subjects with initial recurrence: if the subject received systemic platinum-based adjuvant and/or neoadjuvant chemotherapy，and the recurrence time is more than 6 months from the end of the last chemotherapy，then the previous chemotherapy is allowed.
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  • Group 3: Stage I-IV sarcoma of uterus, and the subject also needs to meet one of the following categories:
  • Newly diagnosed/initial recurrence subject of high grade endometrial stromal sarcoma (ESS)、undifferentiated Uterine sarcoma (UUS) , uterine Leiomyosarcoma and adenosarcoma(uLMS) with sarcoma overgrowth (OS). The definition of new diagnosis and initial recurrence is the same as above.
  • Low grade ESS, adenosarcoma without SO and other Uterine sarcoma with ER+/PR+，the subjects who failed in antiestrogen treatment.
  • According to the RECIST 1.1 criteria, there is at least one measurable lesion. If the measurable lesion is located in the area of previous radiotherapy, it should be clearly defined as progressing state;
  • Tumor tissue samples can be provided to detect MSI/MMR status or traceable test reports;
  • The main organs function well and meet the following standards:
  • Blood routine examination standards (no blood transfusion within 7 days before screening, no correction with hematopoietic stimulating factor drugs):
  • Hemoglobin (HGB) ≥90 g/L;
  • The absolute value of neutrophils (NEUT)≥1.5×109/L;
  • Platelet count (PLT) ≥ 90 × 109/L;
  • The biochemical examination shall meet the following standards:
  • Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN. If accompanied by liver metastasis, ALT and AST≤5×ULN;
  • Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance (Ccr) ≥ 60ml/min;
  • Serum albumin (ALB)>30g/L;
  • Urine routine examination standard: urine routine indicates urine protein <++; if urine protein ≥++, it is necessary to confirm the 24-hour urine protein quantitative ≤1.0g;
  • Coagulation function or thyroid function tests should meet the following criteria:
  • Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5×ULN (no anticoagulation therapy);
  • Thyroid-stimulating hormone (TSH) ≤ ULN; T3 and T4 levels should be investigated if abnormal, and normal T3 and T4 levels can be selected.
  • Echocardiography assessment: Left ventricular ejection fraction (LVEF) ≥50%.
  • 12-lead electrocardiogram evaluation: QTc<470ms.
  • Female subjects should agree that contraceptive measures (such as intrauterine devices or condoms) must be used during the study period and within 6 months after the end of the study; the serum pregnancy test must be negative within 7 days before study enrollment, and must be Non-lactating subjects.

Who cannot join

  • Tumor disease and medical history:
  • Other malignant tumors that have occurred or are currently concurrently present within 3 years. The following conditions were eligible for enrollment: other malignancies treated with a single surgery, achieving 5 consecutive years of disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta ( non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor-infiltrating basement membrane)];
  • Pathologically suggested endometrial leiomyosarcoma, endometrial stromal sarcoma, undifferentiated uterine sarcoma or other high-grade sarcoma (Applicable to group 1 and 2), Pathologically suggested epithelial endometrial cancer or Carcinosarcoma (Applicable to group 3);
  • The presence of tumor thrombus, spinal cord compression caused by bone metastases, brain metastases or cancerous meningitis;
  • Imaging (CT or MRI) shows that the tumor has invaded around important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
  • Severe bone damage caused by tumor bone metastasis; including weight-bearing bone pathological fractures and spinal cord compression that occurred within 6 months or predicted by the investigator to be likely to occur in the near future;
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  • Uncontrolled pleural effusion, pericardial effusion or ascites judged by the investigator that still needs repeated drainage.
  • Previous anti-tumor therapy or concomitant medication (the washout period is calculated from the end of the last treatment):
  • Previously received anti-angiogenesis drugs, related immunotherapy drugs for PD-1, PD-L1, CTLA-4;
  • Received drugs with immunomodulatory function, chemotherapy, radiotherapy, clinical trial drug treatment, traditional Chinese medicine or proprietary Chinese medicine with anti-tumor indications, or other anti-cancer therapy within 4 weeks before receiving the study drug for the first time;
  • Received hormone therapy for endometrial cancer within 1 week before receiving the first study drug treatment;
  • It is not satisfied that at least 5 half-lives have elapsed from the last use of the targeted drug to the first receiving of the study drug, if it is a combination drug, the drug with the longest half-life shall be calculated;
  • Those who have undergone major surgery, major surgical treatment, incisional biopsy, obvious traumatic injury, or have not recovered sufficiently from previous surgery in the judgment of the investigator within 3 weeks before the first treatment with the study drug, or are expected to be required during the study period. Major surgery;
  • The toxicity related to previous anti-tumor therapy has not recovered to CTCAE ≤ grade 1, except for alopecia and grade 2 peripheral neuropathy.
  • Comorbid diseases and medical history:
  • History of liver-related diseases: a. Decompensated cirrhosis; b. Active or chronic hepatitis; c. Bleeding disease secondary to hepatic insufficiency.
  • Kidney related medical history: a. Renal failure requiring hemodialysis or peritoneal dialysis; b. Past or existing nephrotic syndrome, chronic nephritis.
  • Cardiovascular and cerebrovascular related medical history: a. Suffering from epilepsy and requiring treatment; b. New York Heart Association class II-IV heart failure, second-degree or higher heart block, myocardial infarction within the past 6 months or Arterial thrombosis events, unstable arrhythmia or unstable angina; c. Cerebrovascular accident, cerebral infarction, etc. within 6 months; d. If the treatment can adequately control blood pressure, the group is allowed to enter the group; e. Past or current heart valve inflammation, endocarditis; f. Cardiovascular syncope, pathological ventricular arrhythmia.
  • Gastrointestinal-related medical history: a. Inability to take oral medications; b. History of malabsorption syndrome or other diseases that interfere with gastrointestinal absorption; c. Active peptic ulcer or ulcerated lower gastrointestinal tract in the past 6 months Treated for inflammation; d. Persistent chronic diarrhea of grade 2 and above despite maximum medical treatment.
  • Lung-related medical history: a. History of idiopathic pulmonary fibrosis, organized pneumonia, drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia found on chest CT scan during screening; b. Bronchodilator required Medically intervened bronchial asthma; c. The clinical manifestations are suspected to be tuberculosis, T-SPOT positive is judged by the investigator to have tuberculosis infection or active tuberculosis within 1 year before enrollment;
  • Endocrine-related medical history: a. Poor control of type I or II diabetes; b. History of pituitary or adrenal dysfunction; c. Thyroid-stimulating hormone (TSH) > ULN, if T3 and T4 levels are normal, they can be enrolled.
  • Immune-related medical history: a. A history of immunodeficiency, including HIV positive or other acquired and congenital immunodeficiency diseases; b. Organ transplantation planned or previously received, or hematopoietic stem cells received within 60 days before the first dose Transplant, or have obvious host transplant response; c. Active autoimmune disease; d. Systemic or topical immunosuppressive or hormonal therapy is required to achieve immunosuppression, and continue to be used within 7 days before the first dose Glucocorticoids, or patients who still need immunosuppressive drugs within 5 half-lives before the first dose.
  • Bleeding risk: a. Suffering from bleeding (hemoptysis), coagulation disease or using warfarin, aspirin and other antiplatelet aggregation drugs (except aspirin ≤100 mg/d for prophylaxis); b. Regardless of severity, there are any signs or history of bleeding constitution; c. within 4 weeks before the first dose, any CTC AE ≥ grade 3 bleeding or bleeding events;
  • The patient has an active systemic infection or an excessive viral load;
  • Combining serious or not well-controlled diseases or diseases that the investigator determines may have a greater risk or affect the completion of the study, including but not limited to: a. History of clear neurological or mental disorders; b. Treponema pallidum specific antibody positive.
  • Those who have a history of drug abuse and cannot quit or have a history of drug use.
  • Research and treatment related:
  • History of vaccination with live attenuated vaccine within 28 days before the start of study treatment, inactivated vaccine within 7 days, or planned vaccination during the study period;
  • Those who have a history of severe allergic diseases, severe drug allergies, and are known to be allergic to macromolecular protein preparations or TQB2450 injection or any components in the prescription of Anlotinib capsules, their adjuvants and similar drugs;
  • Subjects with insufficient compliance or other reasons are not suitable for enrollment after the investigator's assessment.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong, 510120

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Linyi Cancer Hospital

    Linyi, Shandong, 276002

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200090

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110801

  • Taizhou People's Hospital

    Taizhou, Jiangsu, 225399

  • TianJin Medical University Cancer Institute & Hopspital

    Tianjin, Tianjin Municipality, 300181

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430062

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099

Other trials in China

About this study

Official title: Evaluating the Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for First-line Treatment of Patient With Advanced Endometrial Cancer or Sarcoma of Uterus: a Multi-center, Open-label, Randomized Controlled, Phase II Clinical Trial.

This clinical study plans to enroll 69 endometrial cancer patients and 5-10 uterine sarcoma patients. The trial is divided into a lead-in phase and a main phase. The lead-in phase will include 9 subjects, while the main phase will enroll 60 endometrial cancer patients randomized 1:1. Additionally, 5-10 uterine sarcoma patients will be enrolled. The study aims to evaluate the efficacy and safety of TQB2450 injection combined with chemotherapy ± anlotinib hydrochloride capsules as first-line treatment, followed by TQB2450 injection monotherapy ± anlotinib hydrochloride capsules as maintenance therapy for advanced endometrial cancer or uterine sarcoma. The study will also explore efficacy-related biomarkers, mechanisms of action, safety and/or pathological mechanisms, and surgical conversion rates. The primary endpoint is ORR (Objective Response Rate).

Being tested
TQB2450 injection, Anlotinib Hydrochloride Capsule, Carboplatin Injection, Paclitaxel Injection, Doxorubicin Hydrochloride Injection

What participants receive

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

  • TQB2450 injectionDrug

    TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents the binding of PD-L1 to PD-1 and B7.1 receptors on the surface of T cells, thereby reactivating T cells and enhancing the immune response.

  • Anlotinib Hydrochloride CapsuleDrug

    Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

  • Carboplatin InjectionDrug

    Carboplatin which s similar to alkylating agent, is a second-generation platinum anti-tumor drug, which mainly causes cross-linking of DNA within and between chains, destroys DNA molecules, and disintegrates the helix.

  • Paclitaxel InjectionDrug

    Paclitaxel is a diterpene alkaloid with anticancer activity

  • Doxorubicin Hydrochloride InjectionDrug

    Doxorubicin hydrochloride is a cycle non-specific anticancer chemotherapy drug, which directly acts on DNA, changes the nature of DNA template, and inhibits DNA polymerase.

  • Gemcitabine Hydrochloride InjectionDrug

    Gemcitabine is a cell cycle specific antimetabolic drug, which mainly acts on tumor cells at the DNA synthesis stage.

  • Docetaxel injectionDrug

    Docetaxel is an anti-tumor drug of paclitaxel, which plays an anti-tumor role by interfering with the microtubule network necessary for cell Mitosis and interphase cell function.

Study groups in NCT05481645
Study groupRoleWhat they receive
Group oneExperimentalFirst-line treatment: TQB2450 injection 1200mg,d1/Q3W+Carboplatin Injection, AUC=5 mg/ml.min,d1/Q3W + Paclitaxel Injection 175mg/m2,d1/Q3W;6-8 cycles; Maintenance treatment: TQB2450 injection, 1200mg，d1/Q3W
Receives: Drug: TQB2450 injection; Drug: Carboplatin Injection; Drug: Paclitaxel Injection
Group twoExperimentalFirst-line treatment: TQB2450 Injection 1200mg, d1/Q3W + Anlotinib Hydrochloride Capsules 8mg/qd, d8-21/Q3W + Carboplatin Injection AUC=5 mg/ml.min, d1/Q3W + Paclitaxel Injection 175mg/m2, d1/Q3W ; 6-8 cycles; Maintenance treatment: TQB2450 injection+ Anlotinib Hydrochloride Capsules 8mg/qd, d8-21/Q3W
Receives: Drug: TQB2450 injection; Drug: Anlotinib Hydrochloride Capsule; Drug: Carboplatin Injection; Drug: Paclitaxel Injection
Group threeExperimentalFirst-line treatment stage: TQB2450 injection 1200mg, d1/Q3W + anlotinib hydrochloride capsules 8mg/qd, d8-21/Q3W+ chemotherapy（① Doxorubicin Hydrochloride Injection 60mg/㎡，d1/Q3W; or ② Gemcitabine Hydrochloride Injection 900mg/㎡, d1, d8/Q3W+ Docetaxel Injection 75mg/㎡, d8/Q3W）; 6-8 cycles; Maintenance phase: TQB2450 injection 1200mg, d1/Q3W+ Anlotinib hydrochloride capsules 10mg/qd, d8-21/Q3W
Receives: Drug: TQB2450 injection; Drug: Anlotinib Hydrochloride Capsule; Drug: Doxorubicin Hydrochloride Injection; Drug: Gemcitabine Hydrochloride Injection; Drug: Docetaxel injection

What is being measured

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

  1. Investigator-assessed objective response rate (ORR)

    The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases with complete remission and partial remission

    Measured: Through study completion, an average of 24 months

Secondary outcomes (7)

  1. Progression Free Survival (PFS)

    From randomization to the first occurrence of disease progression or death from any cause. Disease progression refers to tumor growth, or the metastasis of primary tumor lesions, or the discovery of new lesions, etc.

    Measured: From data of randomization until the date of first documented progression or date death from any cause, whichever came first, assessed up to 24 months

  2. Overall survival (OS)

    From randomization to the time of death of death from any cause

    Measured: From date of randomization until the date of death from any cause, assessed up to 60 months

  3. Duration of Remission (DOR)

    The period from the first judgment of complete remission (CR) or partial remission (PR) to the discovery of disease progression (PD).

    Measured: The length of time the patient received this regimen to keep the tumor shrinking, through study completion, an average of 24 months

  4. Disease Control Rate (DCR)

    the proportion of patients whose tumors shrink or remain stable for a certain period of time, including complete remission (CR, Complete Response), partial remission (PR, Partial Response) and stable (SD, stable Disease) cases

    Measured: Through study completion, an average of 24 months

  5. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

    Measured: Baseline to other antitumor therapy, through study completion, an average of 24 months

  6. Abnormal laboratory test indicators

    The incidence of abnormal laboratory test indicators of participants by attachment 1 in the test protocol.

    Measured: Baseline to other antitumor therapy, through study completion, an average of 24 months

  7. The surgical conversion rate

    The proportion of subjects who meet the criteria and undergo radical resection surgery.

    Measured: Baseline to other antitumor therapy, through study completion, an average of 24 months

Timeline

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

  1. First posted1 Aug 2022
  2. Study start26 Aug 2022
  3. Primary completion1 Feb 2024
  4. Study completion30 Nov 2025

Why it stopped: Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05481645
Sponsor's protocol ID
TQB2450-II-14
Status last verified
Nov 2025
First submitted
6 Jul 2022
Last updated
9 Jan 2026
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 TQB2450 injection, Anlotinib Hydrochloride Capsule and Carboplatin Injection in people with Advanced Endometrial Cancer and Sarcoma of Uterus, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 11 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 28 inclusion and 30 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: stopped early, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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?

The study was stopped early (reason given: Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator-assessed objective response rate (ORR) (time frame: Through study completion, an average of 24 months). 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 NCT05481645.

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 9 Jan 2026.

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