AzTrials
AzTrials

Esophageal Squamous Cell CarcinomaPhase 3NCT05244798

Sintilimab Plus NCT or NCRT Versus NCRT for ESCC

A Phase 3 study testing Sintilimab, radiotherapy and Chemotherapy in people with Esophageal Squamous Cell Carcinoma, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Comparative analysis of patients with resectable locally advanced esophageal squamous cell carcinoma treated with neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy combined sintilimab versus neoadjuvant chemoradiotherapy. 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?
Sintilimab, radiotherapy and Chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
1 siteChina
Study dates
1 Nov 2022to 31 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Aged 18 to 75, both sexes;
  • Patients with histologically confirmed locally advanced (cT1N2-3M0 or cT2-4aN0-3M0) thoracic esophageal squamous cell carcinoma (8th UICC-TNM stage);
  • Cervical contrast-enhanced CT showed no suspicious metastatic lymph nodes. Imaging examination showed no systemic metastasis.
  • R0 resection is expected to be achieved;
  • Physical state ECOG 0 ~ 1;
  • No previous antitumor therapy for esophageal cancer, including chemotherapy, radiotherapy (including radiotherapy planned during the study), hormone therapy, and immunotherapy;
Show all 17Show fewer
  • Measurable lesions (according to RECIST v1.1);
  • There was no operation contraindications in the evaluation of various organ functions before operation;
  • The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for study participation:
  • Hemoglobin ≥90g/L;
  • White blood cell count ≥ lower limit of laboratory normal;
  • Neutrophil absolute value (ANC) ≥1.5×109/L;
  • Platelet count ≥100×109/L; Total bilirubin ≤1.5× upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN;
  • Prothrombin time ≤16 seconds and international normalized ratio ≤1.5×ULN; Creatinine ≤1.5×ULN or Cr clearance ≥50 mL/min (calculated using Cockcroft-Gault formula);
  • Fertile women must consent to use effective contraception (e.g. intrauterine devices, birth control pills, or condoms) during the study medication period and within 60 days of the last study medication, have a negative serum pregnancy test within 7 days before study enrollment, and be non-lactating; Men agree that they must use effective contraception during the study medication period and for 60 days after the last study medication;
  • The informed consent must be understood and signed.

Who cannot join

  • Patients who met any of the following criteria were excluded from the study:
  • Malignant tumors other than esophageal cancer (cured localized tumors, including cervical carcinoma in situ, skin basal cell carcinoma and prostate carcinoma in situ, were not excluded) had occurred within 5 years before randomization; Prostate cancer patients receiving hormone therapy with DFS for more than 5 years were not excluded).
  • Patients with high blood tendency who had a history of gastrointestinal bleeding within 6 months before randomization, or had coagulopathy at the time of enrollment, or were receiving thrombolysis or anticoagulant therapy;
  • Severe cardiovascular and cerebrovascular diseases:
  • New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina, myocardial infarction, poorly controlled arrhythmias, or cerebrovascular accidents within 12 months before randomization.
  • LVEF (left ventricular ejection fraction) <50% on echocardiography. Corrected QT interval (QTc) >480ms (calculated using Fridericia's method; if QTc was abnormal, three consecutive tests were performed at 2 min intervals and the mean value was taken).
Show all 23Show fewer
  • Medically difficult to control hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100mmHg) (based on the average of ≥2 measurements).
  • A previous hypertensive crisis or hypertensive encephalopathy.
  • Previous history of interstitial lung disease or pneumonia requiring steroid treatment at enrollment;
  • Had active tuberculosis at the time of randomization, or had received anti-tuberculosis therapy within 1 year before randomization;
  • Asthma at random requiring intermittent use of bronchodilators or other medical interventions;
  • Patients with infectious diseases requiring systemic treatment (oral or intravenous administration) within 4 weeks before randomization; for active hepatitis, effective treatment was required before enrollment;
  • Severe unhealed wounds, active ulcers, and untreated fractures at random;
  • Combined with other inoperable conditions;
  • The previous operation resulted in the inability to use stomach instead of esophagus to reconstruct the digestive tract in this operation;
  • Was receiving systemic steroid therapy (more than 10mg of prednisone daily or equivalent) or other immunosuppressive agents during the 2 weeks prior to randomization;
  • Severe allergy to chemotherapy drugs (albumin paclitaxel or cisplatin) or any monoclonal antibody;
  • Has had an active autoimmune disease requiring systemic treatment (i.e., immunomodulatory drugs, corticosteroids, or immunomodulatory drugs) in the past 2 years; However, replacement therapy (e.g., thyroxine, insulin, or replacement therapy with physiologic corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy and is allowed for use and enrollment;
  • Previous organ transplant recipients;
  • If HBsAg(+) and/or HBcAb(+) are required, HBV DNA must be < 500IU/mL. (If the lower limit of the local center's minimum detectable value is higher than 500IU/mL, after discussion with the sponsor, Enrollment was determined on a case-to-case basis) and continued to receive effective anti-HBV therapy that was already in use during the study period, or entecavir or tenofovir therapy was started prior to study medication;
  • Hcv-rna testing should be performed if HCV antibody is positive, and HCV-RNA>10^3 copy number /mL should be excluded;
  • Co-infection with HIV;
  • In the judgment of the investigator, there are other circumstances that are not suitable for participating in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yongtao Han, M.D. contact

18908178797

hanyongt@aliyun.com

China1 site

  • Sichuan Cancer Hospital and Research Institute

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: Neoadjuvant Chemotherapy or Neoadjuvant Chemoradiotherapy Plus Sintilimab Versus Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: a Multicenter, Randomized, Controlled, Phase III Trial

Comparative analysis of patients with resectable locally advanced esophageal squamous cell carcinoma treated with neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy combined sintilimab versus neoadjuvant chemoradiotherapy.

Read the detailed description

The research process is divided into three stages: firstly, the stage of screening period for 14 days. Qualified subjects will enter the treatment period after completion of screening examination and evaluation. And then, the stage of treatment period: Experimental group (group A) received sintilimab combined with neoadjuvant chemotherapy regimen: preoperative neoadjuvant, sintilimab (D1 administration) combined with chemotherapy (TP regimen: albumin-paclitaxel + carboplatin, D1 administration) for 2 cycles. Every 3 weeks, there was a dosing cycle (Q3W). The experimental group (group B) received neoadjuvant sintilimab combined concurrent chemoradiotherapy: preoperative sintilimab (D1 administration) combined with neoadjuvant concurrent chemoradiotherapy. Chemotherapy regimen: TP regimen: albumin-paclitaxel + carboplatin, D1 administration, 2 cycles. Every 3 weeks, there was a dosing cycle (Q3W). Radiotherapy regimen: according to IMRT treatment plan, the total dose was 41.4Gy, divided into 23 times, 5 days a week. And the control group (group C) received neoadjuvant chemoradiotherapy and the regimen was similar with group B. Surgery was performed 6-8 weeks after completion of neoadjuvant therapy. If the patient without vital tumor cells in primary and lymph nodes after surgery, they only need regular follow-up visit. If the patients with non-pCR resected, those patients need to receive adjuvant immunotherapy. And if the patients with non-R0 resected, the regimen of those patients need to carefully decide based on multidisciplinary team discussed. Lastly, the stage of postoperative assistance, the researchers selected postoperative treatment according to the guidelines for the diagnosis and treatment of esophageal cancer. Patients were followed up for efficacy and safety within 90 days after surgery, once every 3 months for 2 years and once every 6 months for 2-5 years.

Being tested
Sintilimab, radiotherapy, Chemotherapy
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.

  • SintilimabDrug

    Sintilimab: D1 administration) for 2 cycles. Every 3 weeks was a dosing cycle (Q3W)

  • radiotherapyRadiation

    Radiotherapy: According to IMRT treatment plan, the total dose was 41.4Gy, divided into 23 times, 5 days a week.

  • ChemotherapyDrug

    Neoadjuvant chemotherapy with TP regimen: albumin-paclitaxel + carboplatin, D1 administration) for 2 cycles. Every 3 weeks was a dosing cycle (Q3W).

Study groups in NCT05244798
Study groupRoleWhat they receive
Group of sintilimab combined with neoadjuvant chemotherapyExperimentalsintilimab (D1 administration) was given in combination with chemotherapy (TP regimen: albumin-paclitaxel + carboplatin, D1 administration) for 2 cycles. Every 3 weeks, there was a dosing cycle (Q3W). Surgery was performed 6-8 weeks after completion of neoadjuvant therapy. If the patients without vital tumor cells in primary and lymph nodes after surgery, they only need regular follow-up visit. If the patients with non-pCR resected, those patients need to receive adjuvant immunotherapy. And if the patients with non-R0 resected, the regimen of those patients need to carefully decide based on multidisciplinary team discussed.
Receives: Drug: Sintilimab; Drug: Chemotherapy
Group of sintilimab combined with neoadjuvant chemoradiotherapyExperimentalsintilimab (D1) was administered in combination with concurrent chemoradiotherapy. Chemotherapy regimen: TP regimen: albumin-paclitaxel + carboplatin, D1 administration, 2 cycles. Every 3 weeks, there was a dosing cycle (Q3W). Radiotherapy regimen: according to IMRT treatment plan, the total dose was 41.4Gy, divided into 23 times, 5 days a week. Surgery was performed 6-8 weeks after completion of neoadjuvant therapy. If the patients without vital tumor cells in primary and lymph nodes after surgery, they only need regular follow-up visit. If the patients with non-pCR resected, those patients need to receive adjuvant immunotherapy. And if the patients with non-R0 resected, the regimen of those patients need to carefully decide based on multidisciplinary team discussed.
Receives: Drug: Sintilimab; Radiation: radiotherapy; Drug: Chemotherapy
Group of neoadjuvant chemoradiotherapyOtherThe control group received neoadjuvant chemoradiotherapy and the regimen was as follows:Chemotherapy regimen: TP regimen: albumin paclitaxel + carboplatin, D1 administration, 2 cycles. Every 3 weeks, there was a dosing cycle (Q3W). Radiotherapy regimen: according to IMRT treatment plan, the total dose was 41.4Gy, divided into 23 times, 5 days a week. Surgery was performed 6-8 weeks after completion of neoadjuvant therapy. If the patients without vital tumor cells in primary and lymph nodes after surgery, they only need regular follow-up visit. If the patients with non-pCR resected, those patients need to receive adjuvant immunotherapy. And if the patients with non-R0 resected, the regimen of those patients need to carefully decide based on multidisciplinary team discussed.
Receives: Radiation: radiotherapy; Drug: Chemotherapy

What is being measured

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

  1. Pathology complete response rate, pCR

    Definition of pathology complete response is "no cancer cell, including lympho nodes" which corresponds with tumor regression score 0 definition of pathologic response is as follows. Tumor regression score Grade 0 and 1 will be defined as "responder" and 2 and 3 will be considered as "non-responders".

    Measured: 3 months after the surgery

Secondary outcomes (9)

  1. Treatment related adverse event, TRAE

    The TRAE defined as the proportion of participants who have treatment-related adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Event, Version 4.0 (CTCAE v4.0).

    Measured: 3 months after the surgery

  2. Major Pathological Remission rate, MPR

    The residual tumor after neoadjuvant treatment ≤ 10% residual tumor lesion in surgical specimen compared to baseline.

    Measured: 3 months after the surgery

  3. Rate of R0 resection

    Measure the rate of R0 resection with all margins microscopically clear.

    Measured: 3 months after the surgery

  4. Events Free Survival, EFS

    Event-free survival was defined as the time from the date of randomization to the date of the first documented non-fatal event (worsening cardiac function, hospitalization for congestive heart failure, liver function impairment, liver cirrhosis, transformation to AML, as defined in the protocol), or death, whichever occurred first. Participants who did not experience a non-fatal event as of the time of data cut-off (end of study), as well as participants who did not experience a non-fatal event and stopped study participation before the data cut-off, were censored as specified in the protocol.

    Measured: Through study completion, an average of 1 year.

  5. Overall Survival,OS

    Overall survival was the duration from the start of study treatment to death.

    Measured: 5 years after inclusion

  6. disease-free survival, DFS

    DFS is defined as the time interval between the date of random assignment and the date of the first documented evidence of relapse at any site or death related to cancer (including toxicity), whichever occurred first.

    Measured: 5 years after inclusion

  7. Disease Control Rate, DCR

    he Disease Control Rate (DCR) will be defined as the proportion of patients with a best overall response of CR, PR or Stable Disease (SD) (RECIST V1.1) 2 months after randomization

    Measured: 3 years after inclusion

  8. Objective Response Rate, ORR

    The Objective Response Rate (ORR) will be defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) (RECIST V1.1)

    Measured: 3 years after inclusion

  9. Circulating tumor DNA, ctDNA

    Blood will be drawn and tested for ctDNA

    Measured: Before neoadjuvant therapy, before surgery, 1, 6, 12, 18, 24 months after 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 Feb 2022
  2. Study start1 Nov 2022 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05244798
Sponsor's protocol ID
SCCH-TS2201
Status last verified
Oct 2022
First submitted
30 Jan 2022
Last updated
25 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • He W, Bai H, Lv J, Tang P, Hu T, Zhou H, Xiao W, Peng L, Liu G, Wang K, Fang Q, Qi Y, Liang L, Zheng X, Qing H, Chen Y, Zhou Y, Xie W, Han Y, Leng X. Neoadjuvant chemotherapy or chemoradiotherapy plus sintilimab versus neoadjuvant chemoradiotherapy for locally advanced oesophageal squamous cell carcinoma: a study protocol of a multicentre, randomised, controlled, phase III trial (SCIENCE study). BMJ Open. 2025 Jun 4;15(6):e095828. doi: 10.1136/bmjopen-2024-095828.

    PubMed 40467307

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sintilimab, radiotherapy and Chemotherapy in people with Esophageal Squamous Cell Carcinoma, run by Sichuan Cancer Hospital and Research Institute 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 17 inclusion and 23 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: opening soon, as of the sponsor's last update on 25 Oct 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Yongtao Han, M.D. (18908178797, hanyongt@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathology complete response rate, pCR (time frame: 3 months after the surgery). 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 NCT05244798, which also lists 1 linked publication.

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 Oct 2022.

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