A Clinical Trial to Evaluate TQB2858 Injection Combined With Anlotinib Hydrochloride Capsule in the Treatment of Recurrent or Metastatic Advanced Endometrial Carcinoma

NCT05121363 | Unknown Phase 2

• 1 other identifier: TQB2858-II-01
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 2

Brief Summary

A clinical trial to evaluate TQB2858 injection combined with Anlotinib Hydrochloride capsule in the treatment of recurrent or metastatic advanced endometrial carcinoma

Conditions

Endometrial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Proportion of patients whose tumors shrank by a certain amount and remained for a certain period of time, including complete response (CR) and partial response (PR) cases

  Baseline up to two years

Secondary Outcomes (5)

• Progress Free Survival (PFS)

  Baseline up to two years

• Disease Control Rate (DCR)

  Baseline up to two years

• Duration of Response (DOR)

  Baseline up to two years

• Overall Survival (OS)

  Baseline up to two years

• Incidence of adverse events: Occurrence of all adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)

  Baseline up to two years

Study Arms (1)

TQB2858 injection + Anlotinib Hydrochloride capsules

EXPERIMENTAL

TQB2858 injection: once every 3 weeks, 1800mg each time, intravenous infusion. Until the disease progression or unbearable adverse events occur. Anlotinib Hydrochloride capsules: once a day,12mg each time, oral administration before breakfast. Continuous administration for 2 weeks, withdrawal for 1 week, i.e. 3 weeks (21 days) as a course of treatment. Until the disease progression or unbearable adverse events occur.

Drug: TQB2858 injection; Drug: Anlotinib Hydrochloride capsules

Interventions

TQB2858 injection DRUG

TQB2858 is an anti-programmed death receptor 1(anti-PD-1) /Transforming growth factor-β(TGF-β )bi-functional fusion protein

TQB2858 injection + Anlotinib Hydrochloride capsules

Anlotinib Hydrochloride capsules DRUG

Anlotinib Hydrochloride is a multi-target tyrosine kinase inhibitor.

TQB2858 injection + Anlotinib Hydrochloride capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) The subjects voluntarily joined the study, signed the informed consent form;
• (2) Age: 18 -75years old (when signing the informed consent); Performance status score: 0-1;The expected survival time is more than 3 months;
• (3) Endometrial carcinoma confirmed by histopathology;
• (4) Previous treatment with 1-2 line standard systemic chemotherapy regimen failed or intolerated;"intolerance" is defined as ≥ grade IV hematological toxicity or ≥ grade III non-hematological toxicity during treatment. Neoadjuvant or adjuvant chemotherapy is allowed in the early stage. If disease progression / recurrence occurs during neoadjuvant / adjuvant therapy or within 12 months after the end of treatment, neoadjuvant / adjuvant therapy is considered to be a first-line systemic chemotherapy failure for progressive diseases.
• (5)Confirmed to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
• (6)The main organs function well and meet the following standards:
• Blood routine examination standards (correction without blood transfusion and hematopoietic stimulating factor drugs within 14 days before examination): Hemoglobin (HGB) ≥ 80 g / L；The absolute value of neutrophils (NEUT) ≥ 1.5x109 / L；Platelet count ((PLT)) ≥ 90 × 109 PG / L.
• Biochemical examination shall meet the following standards:Total bilirubin (TBIL) ≤ 1.5 times the normal upper limit (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN. If with liver metastasis, ALT and AST ≤ 5 × ULN;Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (Ccr) ≥ 60ml/min.
• Blood coagulation function should meet the following standards: international standardized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy or over five drug half-lives );
• Thyroid function examination should meet the following standards: the thyroid stimulating hormone (TSH) ≤ ULN; if abnormal, the levels of T3 and T4 should be examined. If the levels of T3 and T4 are normal, they can be selected.
• Evaluation by color Doppler echocardiography: left ventricular ejection fraction ((LVEF)) ≥ 50%
• (7) Female subjects of childbearing age should agree that contraceptive measures (such as IUDs or condoms) must be used during the study period and within 6 months after the end of the study; the serum pregnancy/urine pregnancy test is negative within 7 days before the study, and must be non-lactation subjects;male subjects should agree that contraceptive measures must be used during the study period and within 6 months after the end of the study

You may not qualify if:

• Those who meet any of the following criteria will not be enrolled in this study:
• (1) Concomitant disease and medical history:
• Present or present with other malignant tumors within 2 years before medicine for the first time.The following two conditions can be included: other malignant tumors treated by single operation, disease-free survival (DFS) for 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor \[Ta (non-invasive tumor), Tis (in situ) and T1 (tumor infiltrating basement membrane)\]；
• Pathological diagnosis of uterine sarcoma, such as carcinosarcoma (malignant mullerian mixed tumor), endometrial leiomyosarcoma, endometrial stromal sarcoma or other high-grade sarcomas；
• There are a variety of factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.)
• Unalleviated toxicity higher than Common Terminology Criteria for Adverse Events (CTCAE) level 1 due to any previous antineoplastic therapy, excluding alopecia and peripheral sensory nerve disorders;
• Major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment (excluding needle aspiration, endoscopic biopsy for diagnostic purposes, etc.);
• A wound or fracture that has not been cured for a long time, possessing risk factors for fracture (such as bearing bone metastases, etc.)
• Within 6 months before initial administration, there have been arteriovenous thrombotic events such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism,etc;
• Those who have a history of psychotropic substance abuse and are unable to quit or have mental disorders;
• Subjects with any severe and / or uncontrolled disease,including:
• Blood pressure control is not satisfactory after standard treatment(systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg).
• Patients who have experienced myocardial ischemia or myocardial infarction within six months; New York Heart Association(NYHA )grade ≥2 congestive heart failure; Grade ≥2 atrioventricular block; Arrhythmias that cannot be stably controlled with drugs (including corrected QT interva ≥470ms) and arrhythmias that may have a potential impact on trial treatment;
• Active infection ( CTCAE grade ≥ 2 infection);
• Decompensated liver cirrhosis, active hepatitis \*;

Sponsors & Collaborators

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

Study Sites (2)

Hunan Cancer Hospita

Changsha, Hunan, 410013, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Beihua Kong, Doctor

CONTACT

18560081888; kongbeihua@sdu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 16, 2021
• Study Start: December 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 30, 2021

Record last verified: 2021-11

Locations

CN (2)