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Esophageal Squamous Cell CarcinomaPhase 2NCT04229849

Anrotenib Plus Toripalimab Versus Toripalimab in Patients With Advanced Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Anrotenib plus Toripalimab and Toripalimab in people with Esophageal Squamous Cell Carcinoma, run by Henan Cancer Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The aim of this study is to investigate the efficacy and safety of anrotenib plus toripalimab in the treatment of advanced esophageal squamous cell carcinoma. In addition, the investigators will explore the possible mechanisms of anrotinib combined with toripalimab in advanced esophageal squamous cell carcinoma, and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Anrotenib plus Toripalimab and Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
No sites listed yet
Study dates
Jan 2020to Jan 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Confirmed esophageal squamous cell carcinoma patients by histopathological or cytopathological examinations.
  • 2. Advanced esophageal squamous cell carcinoma patients with progression after chemotherapy of taxol and/or platinum or fluorouracil.
  • 3. According to the evaluation criteria of solid tumor efficacy (RESIST 1.1), there should be at least one measurable lesion (empty organs such as esophagus and stomach cannot be taken as the measurable lesion), and the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the previous radiotherapy area is also selected as the target lesion if the lesion progression is confirmed).
  • 4. A histological specimen can be provided for secondary testing.
  • 5. ≥18 years old, male or female.
  • 6. ECOG performance status 0-1.
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  • 7. Life expectancy ≥ 12 weeks.
  • 8. The main organ function meets the following criteria within 7 days before treatment:
  • Blood routine examination criteria (without blood transfusion within 14 days): hemoglobin (HB) ≥ 90g/L, the absolute value of neutrophils (ANC) ≥ 1.5 x 10^9/L, platelet (PLT) ≥ 80 x 10^9/L.
  • Biochemical examinations must meet the following criteria: total bilirubin (TBIL) ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 x ULN, serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance (CCR) ≥ 60 mL/min.
  • Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).
  • 9. Fertile men and women must use effective contraception during the study period and within 6 months after the end of the study.
  • 10. The patient volunteered to participate in the study and signed an informed consent form.

Who cannot join

  • 1.Patients exceeding or currently suffering from other malignant tumors within 5 years, except for cervical cancer in site, non-melanoma skin cancer and superficial bladder tumors (Ta (non-invasive tumor), Tis (in situ carcinoma), and T1 (tumor infiltrating basement membrane)); Patients with rapid progress within 3 months.
  • 2. History of gastrointestinal perforation and/or fistula within 6 months prior to the first administration.
  • 3. Esophageal lesion obviously invading the adjacent organs (major arteries or trachea), resulting in a higher risk of bleeding or fistula.
  • 4. Received any of the following treatment:
  • Previous treatment with anti-PD-1 antibodies or anti-PD-L1 antibodies;
  • Received any experimental drug within 4 weeks prior to the first administration of the study drug;
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  • Enroll in another clinical study, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up;
  • Receive the last dose of anticancer therapy (including radiotherapy, etc.) within 4 weeks before the first administration of the study drug;
  • Patients who need to be given corticosteroids (the equivalent dose of > 10 mg prednisone per day) or other immunosuppressants for systemic treatment within 2 weeks prior to the first use of the study drug, except the use of corticosteroids for esophageal local inflammation and the prevention of allergies, nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical corticosteroid of an equivalent dose of > 10mg prednisone per day is permitted;
  • Received an anti-tumor vaccine or received a live vaccine within 4 weeks prior to the first administration of the study drug
  • Received major surgery or severe trauma within 4 weeks prior to first administration of the study drug.
  • 5. History of immunodeficiency disease, including HIV positive and other acquired or congenital immunodeficiency diseases, or history of organ transplantation allogeneic bone marrow transplantation.
  • 6. Toxicity of previous antitumor treatment did not return to the level ≤NCI CTC AE V5.0 grade 1 (except alopecia) or to the level specified in the inclusion/exclusion criteria.
  • 7. History of allergy to monoclonal antibody or the ingredients of the study drug.
  • 8. Significantly malnourished patients. Exclusion is performed if the patient is receiving intravenous fluids or is required to be hospitalized for continuous infusion therapy. Patients with good nutrition control ≥ 28 days can be enrolled before randomization.
  • 9. Any severe and/or uncontrolled disease, including:
  • Patients with hypertension whose blood pressure can't be well controlled by antihypertensive drugs (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg);
  • Grade 1 or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 480 ms) or grade 2 and above congestive heart failure according to New York Heart Association (MYHA) classification;
  • Severe or uncontrolled disease or active infection (≥ NCI CTC AE V5.0 grade 2), which the investigators believe may increase the risk associated with patient participation and drug administration;
  • Renal failure requiring hemodialysis or peritoneal dialysis;
  • Patients of diabetes who have poor glycemic control (fasting blood glucose (FBG) > 10 mmol/L);
  • Urine routine showed urinary protein ≥ 2 + and 24-hour urine protein quantitation > 1.0 g;
  • Patients of seizures requiring treatment.
  • 10. Any bleeding event ≥ NCI CTC AE V5.0 grade 3 or unhealed wounds, ulcers or fractures in 4 weeks prior to enrollment.
  • 11. Arterial/venous thrombosis events within 3 months, such as cerebrovascular accidents (including transient ischemic attacks), deep venous thrombosis and pulmonary embolism.
  • 12. Active autoimmune diseases or the history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Except patients with vitiligo or childhood asthma/allergies that have been cured and do not require any intervention as adults, autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone, type 1 diabetes using a steady dose of insulin.
  • 13. History of interstitial pulmonary disease (excluding radiation pneumonia without hormone therapy) and non-infectious pneumonia.
  • 14. Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year prior to enrollment but without formal treatment.
  • 15. Patients with active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10^4 copies/mL) and hepatitis C (HCV-RNA higher than the lower limit of the assay).
  • 16. Patients may have other factors that cause them to be forced to terminate the study, such as other serious diseases (including mental illness) that require combined treatment, serious abnormalities in laboratory test, and family or social factors, which may affect the safety of patients or the collection of experimental data.
  • 17. Patients with brain metastases.
  • 18. Woman who is pregnant or nursing.

Trial locations and contacts

No sites are listed yet.

Ying Liu contact

13783604602

yaya7207@126.com

About this study

Official title: A Randomized, Open-label, Controlled, Multicenter Phase II Trial of Anrotenib Plus Toripalimab Versus Toripalimab for Following Treatment of Advanced Esophageal Squamous Cell Carcinoma After Chemotherapy Failure

The aim of this study is to investigate the efficacy and safety of anrotenib plus toripalimab in the treatment of advanced esophageal squamous cell carcinoma. In addition, the investigators will explore the possible mechanisms of anrotinib combined with toripalimab in advanced esophageal squamous cell carcinoma, and screen out biomarkers that can predict the efficacy of combination therapy.

Read the detailed description

There is no standard recommendation for the treatment of advanced esophageal squamous cell cancer after chemotherapy failure. Anrotinib combined with triplizumab have showed synergistic effect in the tumor treatment, and they have demonstrated robust antitumor activity in the first-line treatment of advanced NSCLC with negative driving gene. However, there is no related report on the efficacy in the treatment of advanced esophageal squamous cell carcinoma. The aim of this study is to investigate the efficacy and safety of anrotenib plus toripalimab in the treatment of advanced esophageal squamous cell carcinoma. In addition, the investigators will explore the possible mechanisms of anrotinib combined with toripalimab in advanced esophageal squamous cell carcinoma, and screen out biomarkers that can predict the efficacy of combination therapy.

Being tested
Anrotenib plus Toripalimab, Toripalimab
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • Anrotenib plus ToripalimabDrug

    Also called FOCUS V

    Anrotenib: 10 mg on day 1-14 orally repeated every 21 days; Toripalimab: 240 mg on day 1 intravenously repeated every 21 days.

  • ToripalimabDrug

    Toripalimab: 240 mg on day 1 intravenously repeated every 21 days.

Study groups in NCT04229849
Study groupRoleWhat they receive
Anrotenib plus ToripalimabExperimentalAnrotenib: 10 mg on day 1-14 orally repeated every 21 days; Toripalimab: 240 mg on day 1 intravenously repeated every 21 days; Until disease progression according to the RECIST 1.1 and irRECIST standard, intolerance of toxicity, withdrawal of informed consent from the subject, or tripleuriumab administration up to 2 years.
Receives: Drug: Anrotenib plus Toripalimab
ToripalimabActive comparatorToripalimab: 240 mg on day 1 intravenously repeated every 21 days; Until disease progression according to the RECIST 1.1 and irRECIST standard, intolerance of toxicity, withdrawal of informed consent from the subject, or tripleuriumab administration up to 2 years.
Receives: Drug: Toripalimab

What is being measured

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

  1. Overall Survival (OS)

    From the first day of treatment to death or last survival confirm date

    Measured: up to 2 years

Secondary outcomes (5)

  1. Progression-free Survival (PFS)

    From the first day of treatment until the date of first documented progression or date of death from any cause

    Measured: up to 2 years

  2. Objective Response Rate (ORR)

    To compare objective response rate of the two arms from date of anti-cancer therapy until progression

    Measured: up to 2 years

  3. Disease Control Rate (DCR)

    To compare disease control rate of the two arms from date of anti-cancer therapy until progression

    Measured: up to 2 years

  4. Number of Participants with Treatment-related Adverse Events Treatment-related adverse events

    Number of Participants with Treatment-related Adverse Events Treatment-related adverse events will be assessed by NCI CT CAE v5.0

    Measured: up to 2 years

  5. Assessment of Health-related quality of life

    Quality of Life Questionnaire (QLQ-C30) will be evaluated since treatment begins. At the end of the trail, the differences between the two indicators will be compared with Mixed-effects model repeated measures (MMRM), where the baseline is scored as a covariant and the treatment group as a fixed variable. In addition, the baseline values of the two scores, the value of each visit, and the change value of the baseline will be statistically described.

    Measured: up to 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 posted18 Jan 2020
  2. Study startJan 2020 (estimated)
  3. Primary completionJan 2021 (estimated)
  4. Study completionJan 2022 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
164 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04229849
Sponsor's protocol ID
HNCH-GI-006
Status last verified
Jan 2020
First submitted
13 Jan 2020
Last updated
18 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anrotenib plus Toripalimab and Toripalimab in people with Esophageal Squamous Cell Carcinoma, run by Henan Cancer Hospital.

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 13 inclusion and 32 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

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 Ying Liu (13783604602, yaya7207@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: up to 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 NCT04229849.

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 18 Jan 2020.

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