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Esophageal Squamous Cell Carcinoma (ESCC)Phase 2NCT06709417

A Phase II Clinical Study of Sintilimab Combined with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (NICE-CS)

A Phase 2 study testing Sintilimab, Chemotherapy and radiotherapy in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Shanghai Chest Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of sintilimab combined with chemotherapy, followed by sequential concurrent chemoradiotherapy as conversion therapy, in treatment-naïve esophageal squamous cell carcinoma (ESCC) patients with cT4bN-/+M0 and/or… Read more about this study

Who is it for?
Ages 20 to 75 years
What is being tested?
Sintilimab, Chemotherapy and radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
1 Nov 2024to 31 Dec 2028
Phase
Phase 2
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent prior to the initiation of any study-related procedures.
  • Age: ≥20 years and ≤75 years, no gender restrictions.
  • Diagnosed with esophageal squamous cell carcinoma (ESCC) based on histopathology and imaging, with clinical staging of cT4bN-/+M0 and/or cTanyN+M0 (extracapsular invasion of mediastinal lymph nodes).
  • Thoracic segment esophageal squamous cell carcinoma.
  • Primary lesion is inoperable or inoperable due to extracapsular invasion of mediastinal lymph nodes.
  • ECOG performance status (PS) of 0-1.
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  • Estimated survival time ≥6 months.
  • No prior antitumor therapy for esophageal cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
  • At least one measurable lesion as per RECIST 1.1 criteria.
  • No surgical contraindications based on preoperative evaluation of organ function.
  • Adequate organ function
  • Female participants of childbearing potential must have a negative urine or serum pregnancy test within three days prior to receiving the first dose of study medication (Cycle 1, Day 1). If the urine pregnancy test result is inconclusive, a serum pregnancy test is required. Non-childbearing potential is defined as postmenopausal for at least one year, surgical sterilization, or hysterectomy.
  • Participants of childbearing potential (male or female) must use highly effective contraception methods (with an annual failure rate <1%) throughout the study and for 120 days after the last dose of the investigational drug or 180 days after the last dose of chemotherapy, whichever is longer.

Who cannot join

  • Diagnosis of malignancies other than esophageal cancer within 5 years prior to the first dose of the investigational drug (excluding radically treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the lung, or T1a non-invasive adenocarcinoma).
  • Patients with existing or high-risk tracheoesophageal or aortoesophageal fistulas.
  • Presence of distant metastases.
  • Current participation in an interventional clinical study or receipt of other investigational drugs or devices within 4 weeks prior to the first dose.
  • Prior treatment with anti-PD-1, anti-PD-L1, or any other agents targeting stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).
  • Receipt of systemic antitumor traditional Chinese medicine or immunomodulatory drugs (including thymosin, interferon, or interleukin) within 2 weeks prior to the first dose, except for local use to control pleural effusion.
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  • Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to the first dose, excluding replacement therapy (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency).
  • Use of systemic corticosteroids (excluding nasal, inhaled, or other locally administered corticosteroids) or other immunosuppressive drugs within 7 days prior to the first dose, except for physiological doses of corticosteroids (≤10 mg/day prednisone or equivalent).
  • History of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
  • Known hypersensitivity to active ingredients or excipients in the investigational product.
  • Failure to recover adequately (≤Grade 1 or baseline) from prior therapy-induced toxicities and/or complications prior to initiating treatment (excluding fatigue or alopecia).
  • Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive).
  • Untreated active hepatitis B, defined as HBsAg positivity with HBV DNA levels exceeding the upper limit of normal (ULN) at the study center. Subjects meeting the following criteria are eligible: HBV DNA <1000 copies/mL (200 IU/mL) prior to the first dose and on antiviral therapy during chemotherapy to prevent reactivation. Subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and negative HBV DNA do not require prophylactic antiviral therapy but need close monitoring for reactivation.
  • Active hepatitis C infection, defined as HCV antibody positivity and HCV RNA levels above the lower limit of detection.
  • Receipt of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1), except for injectable inactivated influenza vaccines administered within 30 days prior to the first dose. Intranasal attenuated live influenza vaccines are not allowed.
  • Pregnant or breastfeeding women.
  • History of gastrointestinal bleeding within 6 months prior to treatment or concurrent coagulation disorders, or patients on thrombolytic or anticoagulant therapy with a high risk of bleeding.
  • Any severe or uncontrolled systemic disease, including but not limited to:
  • Major, symptomatic, and poorly controlled abnormalities in cardiac rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation.
  • Unstable angina or congestive heart failure classified as NYHA grade ≥2.
  • Arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, including myocardial infarction, unstable angina, cerebrovascular accidents, or transient ischemic attacks.
  • Poorly controlled blood pressure (systolic BP >140 mmHg, diastolic BP >90 mmHg).
  • History of non-infectious pneumonitis requiring corticosteroid therapy within 1 year prior to the first dose or current clinically active interstitial lung disease.
  • Active pulmonary tuberculosis.
  • Active or uncontrolled infections requiring systemic therapy.
  • Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
  • Liver diseases, such as cirrhosis, decompensated liver disease, or acute/chronic active hepatitis.
  • Poorly controlled diabetes mellitus (fasting blood glucose >10 mmol/L).
  • Proteinuria ≥++ on urinalysis, confirmed by 24-hour urinary protein quantification >1.0 g.
  • Psychiatric disorders that interfere with compliance or treatment.
  • Any history, evidence of disease, abnormal treatment, or laboratory findings that could interfere with study outcomes, impede full participation, or, in the investigator's opinion, render the subject unsuitable for 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.

Jun Liu contact

+862122200000 ext. 3602

drjunliu@qq.com

China1 site, 1 recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

    Jun Liu, M.D., +862122200000 ext. 3602, drjunliu@qq.com

    Recruiting

Other trials in China

About this study

This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of sintilimab combined with chemotherapy, followed by sequential concurrent chemoradiotherapy as conversion therapy, in treatment-naïve esophageal squamous cell carcinoma (ESCC) patients with cT4bN-/+M0 and/or cTanyN+M0 staging (including those with extracapsular invasion of mediastinal lymph nodes).

Being tested
Sintilimab, Chemotherapy, radiotherapy
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 200mg iv Q3W

  • ChemotherapyDrug

    Liposomal paclitaxel: 150mg/m2, Q3W + cisplatin: 75mg/m2, Q3W (combined with PD-1 therapy) Liposomal paclitaxel: 50mg/m2, Q3W + cisplatin: 20mg/m2, Q3W (combined with radiotherapy )

  • radiotherapyRadiation

    The total dose is 5040cCy in 28 fractions (5 days per week, 1.8 Gy/day).

Study groups in NCT06709417
Study groupRoleWhat they receive
Experimental ArmExperimentalEligible participants will first receive two cycles of sintilimab in combination with liposomal paclitaxel and cisplatin. After two cycles, an evaluation will be conducted. Patients deemed eligible for surgery will undergo surgical resection, followed by up to one year of adjuvant sintilimab. The necessity of postoperative adjuvant radiotherapy will be determined by the investigator. For patients deemed ineligible for surgery, concurrent chemoradiotherapy will be administered. Four weeks after the completion of concurrent chemoradiotherapy, a second surgical evaluation will be performed. Patients eligible for surgery at this stage will undergo surgical resection followed by adjuvant sintilimab treatment. Those who remain ineligible for surgery will continue sintilimab treatment after concurrent chemoradiotherapy.
Receives: Drug: Sintilimab; Drug: Chemotherapy; Radiation: radiotherapy

What is being measured

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

  1. 2-yr OS rate

    The percentage of people in the study who are alive two years after the start of treatment.

    Measured: 24 months

Secondary outcomes (6)

  1. R0 resection rate

    The proportion of R0 resections achieved during surgery.

    Measured: 24 months

  2. pCR rate

    pathological complete response (pCR) is defined as no viable residual tumor.

    Measured: 24 months

  3. MPR rate

    The proportion of patients achieved MPR. The major pathologic response (MPR) is defined as residual viable tumor of less than or equal to 10%.

    Measured: 24 months

  4. EFS

    Refers to the time from the start of treatment to the first occurrence of any of the following events: disease progression that is inoperable, local or distant recurrence, death due to any cause, etc.

    Measured: 24 months

  5. OS

    The time from the start of treatment to the death of the subject due to various causes.

    Measured: 24 months

  6. surgical conversion rate

    The proportion of participants assessed as eligible for surgical resection after treatment among the total number of participants.

    Measured: 24 months

Timeline

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

  1. First posted29 Nov 2024
  2. Study start1 Nov 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (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
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06709417
Sponsor's protocol ID
NICE-CS
Status last verified
Nov 2024
First submitted
25 Nov 2024
Last updated
29 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab, Chemotherapy and radiotherapy in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Shanghai Chest Hospital 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 13 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 29 Nov 2024. 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?

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 Jun Liu (+862122200000 ext. 3602, drjunliu@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-yr OS rate (time frame: 24 months). 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 NCT06709417.

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 29 Nov 2024.

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