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

NCT05481645 | Terminated Phase 2

• 1 other identifier: TQB2450-II-14
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 11

Brief 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. 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).

Conditions

Advanced Endometrial Cancer; Sarcoma of Uterus

Outcome Measures

Primary Outcomes (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

  Through study completion, an average of 24 months

Secondary Outcomes (7)

• Progression Free Survival (PFS)

  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

• Overall survival (OS)

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

• Duration of Remission (DOR)

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

• Disease Control Rate (DCR)

  Through study completion, an average of 24 months

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

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

Study Arms (3)

Group one

EXPERIMENTAL

First-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

Drug: TQB2450 injection; Drug: Carboplatin Injection; Drug: Paclitaxel Injection

Group two

EXPERIMENTAL

First-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

Drug: TQB2450 injection; Drug: Anlotinib Hydrochloride Capsule; Drug: Carboplatin Injection; Drug: Paclitaxel Injection

Group three

EXPERIMENTAL

First-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

Drug: TQB2450 injection; Drug: Anlotinib Hydrochloride Capsule; Drug: Doxorubicin Hydrochloride Injection; Drug: Gemcitabine Hydrochloride Injection; Drug: Docetaxel injection

Interventions

TQB2450 injection DRUG

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.

Group one; Group three; Group two

Anlotinib Hydrochloride Capsule DRUG

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

Group three; Group two

Carboplatin Injection DRUG

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.

Group one; Group two

Paclitaxel Injection DRUG

Paclitaxel is a diterpene alkaloid with anticancer activity

Group one; Group two

Doxorubicin Hydrochloride Injection DRUG

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.

Group three

Gemcitabine Hydrochloride Injection DRUG

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

Group three

Docetaxel injection DRUG

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.

Group three

Eligibility Criteria

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

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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;
• 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:

Sponsors & Collaborators

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

Study Sites (11)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430062, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Taizhou People's Hospital

Taizhou, Jiangsu, 225399, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110801, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Linyi Cancer Hospital

Linyi, Shandong, 276002, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264099, China

Location

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200090, China

Location

TianJin Medical University Cancer Institute & Hopspital

Tianjin, Tianjin Municipality, 300181, China

Location

MeSH Terms

Interventions

Carboplatin; Paclitaxel; Doxorubicin; Gemcitabine; Docetaxel

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: August 1, 2022
• Study Start: August 26, 2022
• Primary Completion: February 1, 2024
• Study Completion: November 30, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-11

Locations

CN (11)