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Esophageal Squamous Cell CarcinomaPhase 2NCT04548440

Efficacy and Safety of Preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin in BR-ESCC Patients

A Phase 2 study testing Sintilimab, Nab paclitaxel and Cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Sun Yat-Sen University Cancer Center at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An open-label, non-randomized, phase II study to assess the safety and efficacy of Preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin in Borderline Resectable Esophageal Squamous Cell Carcinoma patients 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?
Sintilimab, Nab paclitaxel and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
31 Aug 2020to 31 Dec 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

  • Patients must provide a signed Informed Consent Form
  • Age ≥18 years old
  • Histological confirmation of T4N0-3M0 thoracic esophageal squamous cell carcinoma, absence of distant metastasis and confirmation of a borderline resectable lesion after multidisciplinary assessment using enhanced CT and/or Endoscopic Esophageal Ultrasound or Endobronchial Ultrasound. The definition of a borderline resectable lesion includes: CT showing that the fat gap between the tumor and the aorta is blurred, the angle between three contiguous planes (2mm/layer) and the aorta exceeds 90 degrees; or Endoscopic Esophageal Ultrasound revealing that the tumor has invaded the adventitia layer of the esophagus, and the boundary with the aorta is unclear; or Endobronchial Ultrasound showing an unclear border between the tumor and trachea or bronchus, but has yet invaded the trachea or bronchial mucosa or submucosa
  • Patients have not received any anti-tumor treatment for esophageal cancer (including surgery, chemotherapy, interventional therapy, immunotherapy, radiotherapy, etc.)
  • Life expectancy ≥3 months
  • General physical status (ECOG PS score) 0-1 points
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  • Blood routine test (within 7 days): Hb ≥9g/L, NE ≥1.5×109/L, PLT ≥90×109/L
  • Liver and kidney function test (within 7 days): total bilirubin ≤1.5 UNL, creatinine ≤1.5× UNL, AST /ALT ≤2.5xUNL, ALP ≤5.0xUNL
  • No serious complications such as active gastrointestinal bleeding, perforation, jaundice, intestinal obstruction, fever unrelated to malignant disease>38℃
  • Patients with reproductive potential should take effective contraceptive measures
  • Patients with good compliance and that can attend scheduled follow up to assess the efficacy and adverse reactions of the treatment

Who cannot join

  • Patients with cervical esophageal squamous cell carcinoma
  • Patients with distant metastases
  • Patients with a high risk of complete esophageal obstruction and require interventional therapy
  • Patients with stent implantation in the esophagus or trachea
  • Patients with an esophageal tumor that invaded adjacent organs (aorta or trachea), causing an increased risk of bleeding or perforation, or patients with a fistula
  • Concurrent primary cancers (except for cured skin basal cell carcinoma and cervical carcinoma in situ)
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  • History of immunosuppressive drug use within 1 week before treatment, excluding nasal spray, inhalation or use of local glucocorticoids or physiological doses of systemic glucocorticoids (not exceeding 10 mg/day prednisone or equivalent doses of other glucocorticoids) or glucocorticoids used to prevent contrast agent allergy.
  • Patients with active or a past history (within 2 years) of autoimmune disease that need symptomatic treatment (Patient diagnosed with vitiligo, psoriasis, alopecia, or Grave disease that did not require systemic treatment within the past 2 years, hypothyroidism that requires only thyroid hormone replacement therapy and type I diabetes patients treated with insulin replacement therapy only are eligible)
  • Patients with a history of primary immunodeficiency disease
  • Patients with a history of active tuberculosis
  • Patients with a past history of allogenic organ transplantation and allogeneic hematopoietic stem cell transplantation
  • Patients diagnosed with interstitial lung disease that require steroid therapy
  • Patients with a known history of allergy to any monoclonal antibody or chemotherapeutic drugs (taxanes, cisplatin) or their constituents.
  • Patients with a history of severe heart disease, including: history of congestive heart failure, patients with high-risk of uncontrolled arrhythmias, angina pectoris requiring medical treatment, clinically diagnosed heart valve disease, history of severe myocardial infarction and refractory hypertension
  • Patients with chronic diarrhea (4 or more watery stools per day) and patient with renal insufficiency
  • Patients with an active infection or an active infectious disease
  • Neurological or mental disorders that affect cognitive ability
  • Pregnant or breastfeeding women
  • Other acute or chronic diseases, mental diseases or laboratory test values that may cause the following abnormal outcomes: Increase participants or drug administration related risks, interfere with the interpretation of the study results, and patients deemed as ineligible to participate in the study based on the investigator's judgment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Phase II Clinical Study of the Efficacy and Safety of Preoperative Sintilimab in Combination With Nab-paclitaxel and Cisplatin in Borderline Resectable Esophageal Squamous Carcinoma

An open-label, non-randomized, phase II study to assess the safety and efficacy of Preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin in Borderline Resectable Esophageal Squamous Cell Carcinoma patients

Read the detailed description

PRIMARY OBJECTIVES:

To determine the R0 resection rate of Borderline Resectable Esophageal Squamous Cell Carcinoma patients who used preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin

SECONDARY OBJECTIVES:

To evaluate the Pathological Complete Response (pCR) rate, Progression Free Survival (PFS), Relapse Rate, Tumor Regression Grading (TRG) post preoperative chemotherapy, Overall Survival (OS), safety and toxicity of chemotherapy regimen and surgery.

EXPLORATORY OBJECTIVES:

Exploring the benefits of this treatment strategy in Borderline Resectable Esophageal Squamous Cell Carcinoma patients at a molecular level

OUTLINE:

Eligible patients receive Sintilimab and cisplatin intravenously on day 1 and albumin-bound paclitaxel intravenously on days 1 and 8. This cycle is repeated every 3 weeks in the absence of disease progression or unacceptable toxicity. Radiological and multidisciplinary assessment is performed after every 2-4 cycles.

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

    Also called Anti-PDCD1 monoclonal antibody IBI308, Tyvyt

    Route of administration: Intravenous

  • Nab paclitaxelDrug

    Also called Nanoparticle Albumin-Bound Paclitaxel, Abraxane

    Route of administration: Intravenously over 30min

  • CisplatinDrug

    Also called CDDP, Platinol

    Route of administration: Intravenous

Study groups in NCT04548440
Study groupRoleWhat they receive
Preoperative Sintilimab plus Nab-paclitaxel and CisplatinExperimentalPatients receive the following regimen every 3 weeks: Sintilimab 200mg IV on Day 1; Albumin-bound paclitaxel 125 mg/m2 IV on Day 1 and Day 8; Cisplatin 75mg/m2 IV on Day 1; Standard hydration regimen on Day 0-3 After 2-4 cycles, radiological evaluation and multidisciplinary assessment will be performed. If radical resection is possible, surgery is to be performed 3-6 weeks after the last chemotherapy session. In the case of a R0 resection, the investigator will decide whether to perform adjuvant therapy depending on the patient's condition; in the case of R1 or R2 resection, concurrent chemoradiotherapy is recommended. If the multidisciplinary assessment considers that radical resection is not possible, radical concurrent chemoradiotherapy is performed.
Receives: Drug: Sintilimab; Drug: Nab paclitaxel; Drug: Cisplatin

What is being measured

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

  1. R0 resection rate of patients who underwent surgery following preoperative treatment

    The proportion of people with a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.

    Measured: up to 28 weeks

Secondary outcomes (6)

  1. Pathological complete response rate of patients who received surgery following preoperative treatment

    The proportion of patients showing an absence of invasive/in situ cancer after treatment

    Measured: up to 28 weeks

  2. Progression free survival from the date of first drug administration until the date of first documented progression or date of death, whichever came first.

    The length of time during and after the treatment of the disease, that a patient lives with the disease without its aggravation

    Measured: up to 28 weeks

  3. Tumor regression rate of patients following preoperative treatment

    A decrease in the size of a tumor or the extent of cancer in the body

    Measured: immediately before surgery

  4. Relapse rate of patients who received surgery following preoperative treatment

    The number of people with deterioration or recurrence of cancer after a temporary improvement

    Measured: up to 28 weeks

  5. Overall survival from the date of first drug administration until the date of death from any cause

    The length of time from the start of treatment that patients diagnosed are still alive

    Measured: up to 28 weeks

  6. Number of patients with adverse events and severity according to NCI CTCAE v5.0

    Summary of the Adverse events experienced during treatment related to the drug used or surgery in this study

    Measured: up to 28 weeks

Timeline

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

  1. First posted14 Sep 2020
  2. Study start31 Aug 2020
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04548440
Sponsor's protocol ID
BRESCC-Preoperative 02
Status last verified
Jun 2025
First submitted
9 Sep 2020
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study Protocol, ICF

Publications

  • Wu JD, Wang DS, Wang ZQ, Li QQ, Xu BY, Ren C, Fang CY, Huang Y, Li ZC, Chen JY, Tan Q, Li YH, Yang H. Sintilimab plus cisplatin and nab-paclitaxel induction treatment for locally advanced borderline-resectable oesophageal squamous cell carcinoma: A single-arm, prospective, phase 2 study (NEOCRTEC2001). Clin Transl Med. 2026 May;16(5):e70691. doi: 10.1002/ctm2.70691.

    PubMed 42112766

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab, Nab paclitaxel and Cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Sun Yat-Sen University Cancer Center 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 11 inclusion and 19 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: finished, as of the sponsor's last update on 12 Jun 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 resection rate of patients who underwent surgery following preoperative treatment (time frame: up to 28 weeks). 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 NCT04548440, 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 12 Jun 2025.

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