A Open-label, Multicenter Phase II Study of TQB2450 Injection or Combined With Anlotinib Hydrochloride Capsule in Subjects With Advanced Endometrial Cancer
Overview
- Phase
- Phase 2
- Intervention
- TQB2450
- Conditions
- Advanced Endometrial Cancer
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 170
- Locations
- 36
- Primary Endpoint
- Overall response rate (ORR) evaluated by Independent Review Committee(IRC)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Understood and signed an informed consent form.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- •Histopathologically confirmed recurrent or metastatic advanced endometrial cancer.
- •Has at least one measurable lesion.
- •Agree to provide tumor tissue samples for MSI/MMR status detection.
- •Adequate laboratory indicators.
- •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:
- •Has diagnosed and/or treated additional malignancy within 3 years prior to randomization;
- •Pathological diagnosed as uterine sarcoma;
- •Has multiple factors affecting oral medication;
- •Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy.
- •Has received major surgical treatment, open biopsy and so on within 28 days before the start of the study.
- •Has a unhealed wound or fracture for a long time;
- •Has cerebrovascular accident, deep vein thrombosis and pulmonary embolism within 6 months before the study;
- •Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures;
- •Has a history of psychotropic substance abuse and unable to quit or mental disorders;
Arms & Interventions
TQB2450 + Anlotinib
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).
Intervention: TQB2450
TQB2450 + Anlotinib
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).
Intervention: Anlotinib
TQB2450
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.
Intervention: TQB2450
Anlotinib
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).
Intervention: Anlotinib
Outcomes
Primary Outcomes
Overall response rate (ORR) evaluated by Independent Review Committee(IRC)
Time Frame: up to 12 months
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on IRC.
Secondary Outcomes
- Progression free survival(PFS)(up to 12 months)
- Overall survival(OS)(up to 18 months)
- DOR rate (≥ 6 months)(up to 6 months)
- Overall response rate (ORR) evaluated by investigator(up to 12 months)
- Disease control rate (DCR)(up to 12 months)
- Duration of response (DOR)(up to 12 months)