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Esophageal Squamous Cell CarcinomaNCT04813406

Study of Anlotinib Plus Sintilimab in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

A study testing Anlotinib + Sintilimab in people with Esophageal Squamous Cell Carcinoma, run by Henan Provincial People's 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 The sponsor has not verified this record for over two years, so it may be out of date.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 purpose of this study is to observe and evaluate the efficacy and safety of anlotinib combined with sindilimab as second-line treatment for advanced esophageal squamous cell carcinoma (ESCC). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Anlotinib + Sintilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
No sites listed yet
Study dates
Mar 2021to Jan 2022
Phase
Interventional
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically (histologically or cytologically) confirmed diagnosis of esophageal squamous cell carcinoma (excluding mixed type adenosquamous carcinoma )
  • Patients undergoing first-line systemic chemotherapy (which may include taxanes, platinum and fluorouracil) progression. For radical concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), if disease progression occurs during treatment or within 6 months after stopping treatment, Count it as a first-line treatment failure.（Note: Patients with advanced or relapsed non target lesions who progress again after radiotherapy alone are included. Palliative treatment for local lesions (non target lesions) lasted for more than 2 weeks.）
  • At least one measurable/evaluable lesion by RECIST v1.1（Cavity organ such as esophagus can not be used as measurable lesions）. And the measurable lesions should not have received local treatment such as radiotherapy (The lesion located in the previous radiotherapy area, if confirmed to progress, and meets the RECIST 1.1 standard, can also be used as a target lesion).
  • 18~80 years, both men and women.
  • Patients who can provide histological specimens for pathological review.
  • Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
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  • Life expectancy of ≥ 12 weeks.
  • The main organs function normally, that is, the following criteria are met:
  • Blood routine examination:
  • HB≥90g/L;
  • ANC ≥ 1.5 × 109 / L;
  • PLT ≥ 80 × 109 / L. (2) Biochemical examination:
  • TBIL ≤ 1.5ULN
  • ALT and AST ≤ 2.5ULN
  • plasma Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min
  • left ventricular ejection fraction (LVEF)≥ normal low limit (50%)
  • Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative before enrollment；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped.
  • Patients should participate in the study voluntarily and sign informed consent.

Who cannot join

  • The patients who had or were suffering from other malignant tumors within 5 years, except for the cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor [ta (non-invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)] and those who developed rapidly within 3 months.
  • Patients with a history of perforation and / or fistula within 6 months before the first medication.
  • Patients with a high risk of bleeding or perforation due to the apparent invasion of adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed fistulas.
  • Have received any of the following treatments:
  • Patients who received Sindilimab therapy or other immunotherapy against PD-1/PD-L1.
  • Patients who have participated in other drug clinical trials within four weeks.
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  • Enter another clinical study, unless it is an observational (non intervention) clinical study or an intervention clinical study.
  • Receive the last dose of anticancer treatment (including radiotherapy, etc.) within ≤ 4 weeks before the first use of the study drug.
  • The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose >10 mg/day of prednisone ) and continues to be used within 2 weeks prior to enrollment, except for the use of corticosteroids for local esophageal inflammation and prevention of allergy, nausea and vomiting. In the absence of active autoimmune diseases, inhaled or topical corticosteroids and corticosteroid replacement with a therapeutic dose of prednisone greater than 10 mg / day are permitted.
  • Patients who had been vaccinated with anti-tumor vaccine or had been vaccinated with live vaccine within 4 weeks before the first administration of the study drug.
  • The patient had major surgery or severe trauma within 4 weeks before the first use of the study drug.
  • A history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
  • The toxicity of previous anti-tumor therapy did not return to ≤ NCI CTC AE v5.01 (except alopecia) or the level specified in the inclusion / exclusion criteria.
  • Allergic to monoclonal antibody and anlotinib
  • Patients with significant malnutrition. If the patient is receiving intravenous infusion of nutrient solution or requires hospitalization for continuous infusion treatment, then exclusion. Before randomization, patients with good nutrition control for more than 28 days can be enrolled.
  • Patients with any severe and / or uncontrolled disease, include:
  • Patients with hypertension who can not be well controlled by antihypertensive drugs (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg).
  • With myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 480ms) and ≥ 2 congestive heart failure (NYHA classification).
  • Serious or uncontrolled disease or active infection (≥ NCI CTC AE V5.02 infection), which the researchers believe will increase the risk related to research participation, drug delivery or affect the ability of subjects to receive the study drug.
  • Renal failure requires hemodialysis or peritoneal dialysis.
  • Poor glycemic control in diabetic patients (FBG > 10mmol / L).
  • Routine urine showed that urinary protein was ≥ 2+ and 24-hour urinary protein was confirmed to be more than 1.0g.
  • Patients with epilepsy and need treatment.
  • 4 weeks before of enrollment; any sites of bleeding NCI CTC AE grade ≥3, such as unhealed wounds, ulcers or fractures.
  • Patients with arteriovenous thrombosis events within 3 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism;
  • The patient has any active autoimmune disease (such as the following, but not limited to: Interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adult, autoimmune hypothyroidism treated with stable dose of thyroid replacement hormone and type I diabetes treated with stable dose of insulin.
  • The patient has a history of interstitial lung disease (except radiation pneumonia without hormone therapy) and non infectious pneumonia.
  • Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within one year before enrollment, or with a history of active pulmonary tuberculosis infection more than one year ago but without regular treatment;
  • Patients with active hepatitis B (HBV-DNA ≥ 104 copy number / ml or 2000 IU / ml) Or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method).
  • According to the judgment of the researcher, there are other factors that may cause the subject to be forced to terminate the study, such as suffering from other serious diseases (including mental illness) requiring combined treatment, serious laboratory abnormalities, family or social factors, which may affect the safety of the subject or the collection of experimental data
  • Symptomatic central nervous system metastasis and/or cancerous meningitis are known to exist.
  • Pregnant or lactating women.

Trial locations and contacts

No sites are listed yet.

Jianwei Zhou, Doctor contact

0086-13937120756

drzhoujw@126.com

About this study

Official title: Anlotinib in Combination With Sintilimab as Second-line Treatment for Advanced Esophageal Squamous Cell Carcinoma (ESCC) : a Multicenter, Single-arm, Open-label Phase Ⅱ Clinical Trial

The purpose of this study is to observe and evaluate the efficacy and safety of anlotinib combined with sindilimab as second-line treatment for advanced esophageal squamous cell carcinoma (ESCC). In addition, we also explored the possible mechanism of anlotinib combined with sindilimab in order to screen out biomarkers that can predict the efficacy of the combination therapy.

Read the detailed description

China is one of the regions with the highest risk of esophageal cancer in the world, and more than 90% of esophageal cancer is squamous cell carcinoma (SCC). The incidence of esophageal cancer is ranked sixth and the mortality rate ranks fourth in China. At present, the first-line treatment of advanced esophageal cancer is mainly based on the combination of paclitaxel, cisplatin and fluorouracil. After the failure of first-line treatment, there is no standard second-line treatment. The investigators designed a multicenter, single-arm, open-label phase Ⅱ clinical trial of anlotinib combined with sindilimab as second-line treatment for advanced esophageal squamous cell carcinoma (ESCC).

Being tested
Anlotinib + Sintilimab
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.

  • Anlotinib + SintilimabDrug

    Anlotinib: 1 capsule (10mg) once a day, d1-d14 per cycle, 3 weeks for a treatment cycle.

    Sintilimab: 200 mg/time, intravenous injection, every 3 weeks is one cycle.

Study groups in NCT04813406
Study groupRoleWhat they receive
Anlotinib + SintilimabExperimentalNot described
Receives: Drug: Anlotinib + Sintilimab

What is being measured

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

  1. Overall survival(OS)

    From date of randomization until the date of death from any cause

    Measured: up to 2 year

Secondary outcomes (3)

  1. Progress free survival (PFS)

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

    Measured: up to 2 year

  2. Objective Response Rate (ORR)

    From date of randomization until the date of death from any cause

    Measured: up to 1 year

  3. Disease Control Rate (DCR)

    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD)

    Measured: up to 1 year

Timeline

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

  1. First posted24 Mar 2021
  2. Study startMar 2021 (estimated)
  3. Primary completionJan 2022 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04813406
Sponsor's protocol ID
2020-115-02
Status last verified
Mar 2021
First submitted
21 Mar 2021
Last updated
24 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Anlotinib + Sintilimab in people with Esophageal Squamous Cell Carcinoma, run by Henan Provincial People's 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 18 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 24 Mar 2021. 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.

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 Jianwei Zhou, Doctor (0086-13937120756, drzhoujw@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 year). 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 NCT04813406.

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 24 Mar 2021.

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