Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Cap… (NCT05481645) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.
Stopped: Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
China71 participantsStarted 2022-08-26
Plain-language 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).
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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.
✓. Blood routine examination standards (no blood transfusion within 7 days before screening, no correction with hematopoietic stimulating factor drugs):
✕. 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.
✕. 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;