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Advanced Biliary Tract CancerPhase 2NCT05812430

Anlotinib Plus TQB2450 Combined With Nab-paclitaxel and Cisplatin as First-line Treatment for Advanced Biliary Tract Cancer

A Phase 2 study testing anlotinib+TQB2450+nab-paclitaxel+cisplatin in people with Advanced Biliary Tract Cancer, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Biliary Tract Cancer
What is being tested?
anlotinib+TQB2450+nab-paclitaxel+cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
10 Apr 2023to 10 Oct 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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;

Trial locations and contacts

1 site in 1 country.

Hong Zong, doctor contact

0086-13523586882

zonghong522@126.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Hong Zong

    Recruiting

Other trials in China

About this study

Official title: 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

Being tested
anlotinib+TQB2450+nab-paclitaxel+cisplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anlotinib+TQB2450+nab-paclitaxel+cisplatinDrug

    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.

Study groups in NCT05812430
Study groupRoleWhat they receive
anlotinib+TQB2450+nab-paclitaxel+cisplatinExperimentalNot described
Receives: Drug: anlotinib+TQB2450+nab-paclitaxel+cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate(ORR)

    The RECIST1.1 standards were used to evaluate the efficacy of drugs.

    Measured: about 2 years

Secondary outcomes (3)

  1. Progression Free Survival(PFS)

    Measured: about 2 years

  2. Overall Survival(OS)

    Measured: about 2 years

  3. Disease Control Rate(DCR)

    Measured: about 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2023
  2. Study start10 Apr 2023
  3. Primary completion10 Oct 2023 (estimated)
  4. Study completion10 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05812430
Sponsor's protocol ID
BTC-01
Status last verified
Sep 2023
First submitted
13 Mar 2023
Last updated
13 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anlotinib+TQB2450+nab-paclitaxel+cisplatin in people with Advanced Biliary Tract Cancer, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hong Zong, doctor (0086-13523586882, zonghong522@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate(ORR) (time frame: about 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05812430.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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