A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule in Subjects With Advanced Endometrial Cancer

CTTQ

Status and phase: Completed; Phase 2

Conditions: Advanced Endometrial Cancer

Treatments: Drug: Anlotinib; Drug: TQB2450

Study type: Interventional

Funder types: Industry

Identifiers

NCT04574284

TQB2450-II-08

Details and patient eligibility

About

This is a study to evaluate the efficacy and safety of TQB2450 injection or combined with anlotinib hydrochloride capsule in the treatment of recurrent or metastatic advanced endometrial cancer.

Enrollment: 170 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Understood and signed an informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.

  2. Histopathologically confirmed recurrent or metastatic advanced endometrial cancer.

  3. Has at least one measurable lesion. 5. Agree to provide tumor tissue samples for MSI/MMR status detection. 6. Adequate laboratory indicators. 7. Serum or urine pregnancy tests are negative within 7 days before randomization; Men and women should agree to use effective contraception during the study period and after the end of the study period within 6 months.

Exclusion criteria

• 1.Concomitant disease and medical history:

  1. Has diagnosed and/or treated additional malignancy within 3 years prior to randomization;
  2. Pathological diagnosed as uterine sarcoma;
  3. Has multiple factors affecting oral medication;
  4. Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy.
  5. Has received major surgical treatment, open biopsy and so on within 28 days before the start of the study.
  6. Has a unhealed wound or fracture for a long time;
  7. Has cerebrovascular accident, deep vein thrombosis and pulmonary embolism within 6 months before the study;
  8. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures;
  9. Has a history of psychotropic substance abuse and unable to quit or mental disorders;
  10. Has any serious and / or uncontrolled disease; 2. Tumor-related symptoms and treatment:
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  1. Has received surgery, chemotherapy, radiotherapy or other anticancer therapy within 4 weeks before the start of the study;
  2. Has received proprietary Chinese medicine with anti-tumor indications in the NMPA approved drug instructions within 2 weeks before the start of the study;
  3. Has received immunotherapeutic drugs against PD-1, PD-L1, CTLA-4 and other related drugs;
  4. Has used antiangiogenic drugs such as bevacizumab, anlotinib, apatinib, lenvatinib, sorafenib, Sunitinib, regorafenib, fruquintinib, etc;
  5. Has received hormone therapy for endometrial cancer within a week before the first dose ;
  6. CT or MRI showed that the tumor had invaded the important blood vessels;
  7. Has symptomatic central nervous system (CNS) disease and/or cancerous meningitis, pia mater disease; 3. Related to research and treatment:
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  1. Has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period.

  2. Has a history of severe allergic diseases.

  3. Has active autoimmune diseases requiring systemic treatment occurred within 2 years before the study.

     4. Has Participated in other clinical trials within 4 weeks before first dose. 5. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 3 patient groups

TQB2450 + Anlotinib

Experimental group

Description:

TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Treatment:

Drug: TQB2450

Drug: Anlotinib

TQB2450

Experimental group

Description:

TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.

Treatment:

Drug: TQB2450

Anlotinib

Experimental group

Description:

Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Treatment:

Drug: Anlotinib