- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05812430
Anlotinib Plus TQB2450 Combined With Nab-paclitaxel and Cisplatin as First-line Treatment for Advanced Biliary Tract Cancer
September 9, 2023 updated by: Hong Zong, The First Affiliated Hospital of Zhengzhou University
The Efficacy and Safety of Anlotinib Plus TQB2450 Combined With Nab-paclitaxel and Cisplatin as First-line Treatment for Advanced Biliary Tract Cancer
To evaluate the efficacy and safety of anlotinib plus TQB2450 combined with nab-paclitaxel and cisplatin as first-line treatment for advanced biliary tract cancer
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hong Zong, doctor
- Phone Number: 0086-13523586882
- Email: zonghong522@126.com
Study Locations
-
-
-
Zhengzhou, China
- Recruiting
- The First Affiliated Hospital of Zhengzhou University
-
Contact:
- Hong Zong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 1. Age: 18-75 years old; both male and female are eligible.
- 2. Pathologically confirmed unresectable, untreated gallbladder cancer or intrahepatic/extrahapatic cholangiocarcinoma with at least one measurable lesion according to RECIST v1.1. Tissue samples must be provided for biomarker analysis, preferably newly acquired tissue. If newly acquired tissue is not available, 5-8 archived paraffin sections with a thickness of 5um must be provided.
- 3. ECOG score: 0-1.
- 4. Expected survival period ≥12 weeks.
- 5. Normal function of major organs, which meets the following criteria: Blood routine test: a) Hb ≥ 90 g/L (no blood transfusion within 14 days); b) ANC ≥ 1.5x 10^9/L; c) PLT ≥ 80x 10^9/L; Biochemical test: a) ALB ≥ 30g/L (no albumin transfusion within 14 days); b) ALT and AST <2.5ULN; if there is liver metastasis, ALT and AST ≤5ULN; c) TBIL ≤ 1.5ULN; d) plasma Cr ≤ 1.5ULN; or creatinine clearance rate (CCr) ≥60ml/min.
- 6. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).
- 7. Participants must voluntarily agree to join the study, sign an informed consent form, and be able to comply with the visit and related procedures specified in the protocol. Female participants of childbearing potential or male participants whose partner is of childbearing potential must take effective contraceptive measures throughout the treatment period and for 6 months after the end of treatment.
Exclusion Criteria:
- 1. Confirmed allergy to anlotinib hydrochloride and/or its excipients, and TQB-2450 components;
- 2. Uncontrolled hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), grade I or higher coronary heart disease, grade I arrhythmia (including QTc interval prolongation of >450 ms in males and >470 ms in females), and heart failure with urine protein positive;
- 3. Patients with clear gastrointestinal bleeding tendencies, including local active ulcer lesions and fecal occult blood (++), cannot be included. Patients with a history of black stool or vomiting within 2 months cannot be included;
- 4. Patients with abnormal coagulation function (INR > 1.5, APTT > 1.5 ULN) with a tendency to bleed;
- 5. Patients with multiple factors affecting oral drug absorption (such as dysphagia, nausea, vomiting, chronic diarrhea, and bowel obstruction, etc.);
- 6. Patients with central nervous system metastases;
- 7. Pregnant or lactating women;
- 8. Patients with other malignant tumors within 5 years (excluding cured skin basal cell carcinoma and cervical intraepithelial neoplasia);
- 9. Patients with a history of substance abuse that cannot be overcome or with mental illness;
- 10. Patients who participated in another drug clinical trial within 4 weeks;
- 11. Patients who have received VEGFR inhibitors such as sorafenib, sunitinib, or apatinib;
- 12. Patients with unhealed wounds or fractures;
- 13. Patients with abnormal thyroid function;
- 14. Urine protein ≥++ or 24-hour urine protein quantity greater than 1.0g;
- 15. Received target focus radiotherapy within 4 weeks prior to the first dose of study therapy;
- 16. Use of immunosuppressive drugs within 4 weeks prior to the first dose of study therapy, excluding nasal, inhalation or other routes of topical corticosteroids or physiological doses of systemic corticosteroids (i.e., not exceeding 10 mg/ day of prednisone or equivalent doses of other corticosteroids);
- 17. Receive live attenuated vaccine within 4 weeks before the first dose of study treatment or during the study period;
- 18. Had major surgical procedures (craniotomy, thoracotomy or laparotomy) or unhealed wounds, sores or fractures within 4 weeks prior to the first dose of study treatment;
- 19. Class 0 or 1 toxicity (excluding hair loss, non-clinically significant, and asymptomatic laboratory abnormalities) that did not return to National Cancer Institute General Adverse Event Terminology 4.03 (NCI CTCAE 4.03) due to prior antitumor therapy prior to the first dose of study therapy;
- 20. Symptomatic central nervous system metastases and/or cancerous meningitis are known. Subjects who had previously received BMS Eligible for study participation if BMS have remained stable for at least 4 weeks prior to the first dose of investigational therapy; And neurological symptoms must have returned to NCI CTCAE 4.03 level 0 or 1;
- 21. Active, known or suspected autoimmune disease or previous 2-year history of the disease (patients with vitiligo, psoriasis, alopecia, or Grave's disease that did not require systemic treatment within the last 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type 1 diabetes requiring only insulin replacement therapy were included);
- 22. Uncontrolled co-morbidity includes, but is not limited to: HIV-infected persons (HIV-antibody positive). Severe infections that are active or poorly controlled clinically;
- 23. Symptomatic congestive heart failure (New York Heart Association Grade II-IV) or symptomatic or poorly controlled arrhythmias.
- 24. Uncontrolled arterial hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) even with standard treatment;
- 25. Any arterial thromboembolic event, including myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred in the 6 months prior to admission for treatment;
- 26. Significant malnutrition, such as the need for intravenous nutritional solutions; Malnutrition corrected for more than 4 weeks prior to the first dose of study therapy was excluded;
- 27. A history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within the 3 months prior to enrollment (implantable port of intravenous infusion or catheter-derived thrombosis, or superficial venous thrombosis was not considered "severe" thromboembolism);
- 28. Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or cancers that may lead to higher medical risk and/or uncertainty in the assessment of survival;
- 29. Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis;
- 30. A history of ileus or the following: inflammatory bowel disease or extensive enterectomy (partial resection of the colon or extensive resection of the small intestine with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea;
- 31. Other acute or chronic diseases, psychiatric disorders, or abnormalities in laboratory test values that may increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and, in the investigator's judgment, classify patients as ineligible for study participation;
- 32. Known to have acute or chronic active hepatitis B (HBsAg positive with HBV DNA≥200 IU/mL or ≥103 copies /mL) or acute or chronic active hepatitis C (HCV antibody positive with HCV RNA positive);
- 33. A history of gastrointestinal perforation and/or fistula during the 6 months prior to study inclusion;
- 34. Suffers from interstitial lung disease;
- 35. Pregnant or nursing female patients;
- 36. Known history of primary immunodeficiency;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: anlotinib+TQB2450+nab-paclitaxel+cisplatin
|
Anlotinib: 10mg, po, d1~14, q3w, until disease progression or unacceptable toxicity. TQB2450: 1200mg, ivgtt, d1, q3w, until disease progression or unacceptable toxicity. nab-paclitaxel: 200mg/㎡, ivgtt, d1, q3w, 6 cycles. cisplatin: 60mg/㎡, ivgtt, d1, q3w, 6 cycles. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate(ORR)
Time Frame: about 2 years
|
The RECIST1.1 standards were used to evaluate the efficacy of drugs.
|
about 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free Survival(PFS)
Time Frame: about 2 years
|
about 2 years
|
Disease Control Rate(DCR)
Time Frame: about 2 years
|
about 2 years
|
Overall Survival(OS)
Time Frame: about 2 years
|
about 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2023
Primary Completion (Estimated)
October 10, 2023
Study Completion (Estimated)
October 10, 2024
Study Registration Dates
First Submitted
March 13, 2023
First Submitted That Met QC Criteria
April 2, 2023
First Posted (Actual)
April 13, 2023
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 9, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Digestive System Neoplasms
- Biliary Tract Diseases
- Biliary Tract Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
Other Study ID Numbers
- BTC-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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