AzTrials
AzTrials

Esophageal Squamous Cell CarcinomaPhase 2NCT04514835

A Phase Ⅱ Trials of Sintilimab as Consolidation Therapy After Radical Concurrent Chemoradiotherapy in Locally Advanced Unresectable ESCC

A Phase 2 study testing Cisplatin+Capecitabine+Sintilimab in people with Esophageal Squamous Cell Carcinoma, 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

The purpose of this study is to observe and evaluate the efficacy and safety of Sintilimab for Consolidation Therapy After Radical Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Cisplatin+Capecitabine+Sintilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
1 Dec 2021to 31 Jan 2023
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 men and women; 2. Histology confirmed as esophageal squamous cell carcinoma; 3. T1bN+M0, T2-T4aN0-2M0 locally advanced stage； 4. Tissue samples should be provided for biomarker analysis, and the newly obtained tissues should be selected. Patients who cannot provide newly obtained tissues can provide 5-8. pieces of 5-um thick paraffin sections; 5. ECOG: 0~1; 6. Expected survival period ≥ 12 weeks; 7. 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;
  • Biochemical examination:
  • ALB ≥ 30g / L;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 (CCr) ≥ 60ml / min; 8.Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%); 9. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment And must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 10. Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.

Who cannot join

  • Does not meet the above inclusion criteria;
  • Those who are allergic to or sensitive to capecitabine and cisplatin or metabolic disorders;
  • The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis,Hyperthyroidism; patients with vitiligo ; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
  • The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppressive purposes (dose> 10 mg/day of prednisone or other therapeutic hormones) and continues to be used for 2 weeks prior to enrollment;
  • contraindications to radiotherapy;
  • Patients with any severe and/or uncontrolled diseases:Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100 mmHg); myocardial ischemia or myocardial infarction with grade I or above, arrhythmia (including QT interval ≥ 480ms) and grade I cardiac insufficiency;
Show all 16Show fewer
  • Active or uncontrolled serious infections;
  • Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 104 copies/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);
  • Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation> 1.0g;
  • The patients whose imaging showed that the tumor had invaded the important vessels or the tumor was likely to invade the important vessels and cause fatal hemorrhage during the follow-up study;
  • Pregnant or lactating women;
  • Patients with other malignancies within 5 years (except for basal cell carcinoma and cervical carcinoma in situ) that have been cured;
  • Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
  • Patients who have participated in other drug clinical trials within four weeks;
  • At the discretion of the investigator, there are patients with serious concomitant disease that compromises patient safety or affects the patient's completion of the study;
  • The investigator believes that it is not suitable for inclusion.

Trial locations and contacts

1 site in 1 country.

Feng Wang contact

13938244776

fengw010@163.com

China1 site

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450001

    Feng Wang, doctor

Other trials in China

About this study

The purpose of this study is to observe and evaluate the efficacy and safety of Sintilimab for Consolidation Therapy After Radical Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Read the detailed description

In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents.We designed a single-arm, open-label, phase II trial of Sintilimab for consolidation therapy after radical concurrent chemoradiotherapylocally advanced esophageal squamous cell carcinoma.The purpose of this study is to observe and evaluate the efficacy and safety of Sintilimab for consolidation therapy after radical concurrent chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.

Being tested
Cisplatin+Capecitabine+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.

  • Cisplatin+Capecitabine+SintilimabDrug

    The first stage:concurrent chemoradiotherapy，cisplatin，25-30mg/m2 ivgtt d1;capecitabine,800mg/m2, bid d1-5，qw，5weeks;concurrent radiotherapy,1.8-2Gy/d，5d/W，50-50.4Gy.

    second stage:Sintilimab, 200mg,q3w, a total of 3 times，Each infusion lasted for 30-60 min until disease progression or intolerable toxicity, with a maximum duration of no more than 12 months.

Study groups in NCT04514835
Study groupRoleWhat they receive
Cisplatin+Capecitabine+SintilimabExperimentalCisplatin+Capecitabine+Sintilimab
Receives: Drug: Cisplatin+Capecitabine+Sintilimab

What is being measured

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

  1. Progression-free survival（PFS）

    Evaluation of anti-PD-1 antibody Sintilimab for progression-free survival in patients with locally advanced unresectable esophageal squamous cell carcinoma who did not develop disease after radical concurrent chemoradiotherapy

    Measured: up to 1 year

Secondary outcomes (1)

  1. Objective Response Rate，ORR

    To evaluate the objective response rate (objective response rate, ORR) of Sintilimab in patients with locally advanced esophageal squamous cell carcinoma who have not progressed after concurrent radiotherapy and chemotherapy

    Measured: At time of surgery

Timeline

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

  1. First posted17 Aug 2020
  2. Study start1 Dec 2021 (estimated)
  3. Primary completion31 Jan 2022 (estimated)
  4. Study completion31 Jan 2023 (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
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04514835
Sponsor's protocol ID
IBI308-01
Status last verified
Aug 2021
First submitted
5 Aug 2020
Last updated
25 Aug 2021
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 Cisplatin+Capecitabine+Sintilimab in people with Esophageal Squamous Cell Carcinoma, 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 16 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 25 Aug 2021. 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 Feng Wang (13938244776, fengw010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival（PFS） (time frame: up to 1 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 NCT04514835.

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 25 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in