Clinical trial NCT04574284: A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule in Subjects With Advanced Endometrial Cancer
Official title: A Open-label, Multicenter Phase II Study of TQB2450 Injection or Combined With Anlotinib Hydrochloride Capsule in Subjects With Advanced Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Endometrial Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

  3. Histopathologically confirmed recurrent or metastatic advanced endometrial cancer.

  4. 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.

Primary outcomes:
measure: Overall response rate (ORR) evaluated by Independent Review Committee(IRC)
timeFrame: up to 12 months
Secondary outcomes:
measure: Overall response rate (ORR) evaluated by investigator
timeFrame: up to 12 months
measure: Disease control rate (DCR)
timeFrame: up to 12 months
measure: Duration of response (DOR)
timeFrame: up to 12 months
measure: Progression free survival(PFS)
timeFrame: up to 12 months
measure: Overall survival(OS)
timeFrame: up to 18 months
measure: DOR rate (≥ 6 months)
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Lanzhou
country: China
facility: Gansu Provincial Hospital
state: Gansu
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Lanzhou
country: China
facility: Gansu Province Maternity and Chid-care Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
state: Guangxi
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: Xi'an People's Hospital
state: Shanxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Central Hospital of Gynecology Obstetrics
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Shihezi
country: China
facility: First Affiliated Hospital, School of Medicine, Shihezi University
state: Xinjiang Uygur Autonomous Region
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang Uygur Autonomous Region
city: Urumqi
country: China
facility: Xinjiang Medical University Affiliated Tumor Hospital
state: Xinjiang Uygur Autonomous Region
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
Study officials:
References: