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Squamous Cell Esophageal CarcinomaPhase 3NCT05357846

PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

A Phase 3 study testing Sintilimab, Preoperative radiotherapy and Paclitaxel in people with Squamous Cell Esophageal Carcinoma and Esophageal Cancer, run by Sun Yat-sen University 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
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Trial summary

The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Sintilimab, Preoperative radiotherapy and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
422 participants
Where
1 siteChina
Study dates
1 Nov 2022to 31 Jan 2031
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.
  • Patients must not have received any prior anticancer therapy.
  • More than 6 months of expected survival.
  • Age ranges from 18 to 70 years.
  • Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
  • WHO PS score 0-1
  • Signed informed consent document on file.

Who cannot join

  • Patients have received any prior anticancer therapy.
  • Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.
  • Patients with concomitant hemorrhagic disease.
  • Patients who cannot tolerate surgery.
  • Pregnant or breast feeding.
  • Patients without informed consent because of psychological, family, social or any other factors.
Show all 14Show fewer
  • Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
  • Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
  • Patients with history of diabetes over 10 years and unsatisfactory glycemic control.
  • Patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery.
  • Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation.
  • Patients with history of interstitial lung disease or noninfectious pneumonia.
  • Patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment.
  • Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).

Trial locations and contacts

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

HONG YANG, M.D. Ph.D. contact

8602087343 ext. 8602087343

yanghong@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Hong Yang, Ph.D.,M.D., 008613560405144, yanghong@sysucc.org.cn

    Jiyang Chen, 008618826238208, chenjy1@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: Phase III Multicenter Randomized Controlled Trial of PD-1 Inhibitor Combined With Preoperative Concurrent Chemoradiotherapy and Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC2101)

The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.

Being tested
Sintilimab, Preoperative radiotherapy, Paclitaxel, Cisplatin, esophagectomy
Medical subject headings
Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SintilimabDrug

    Sintilimab 200mg, IV (in the vein) on day 1 and day 22

  • Preoperative radiotherapyRadiation

    External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.

  • PaclitaxelDrug

    Also called Taxol

    50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22

  • CisplatinDrug

    Also called DDP

    25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22

  • esophagectomyProcedure or surgery

    McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 6-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.

Study groups in NCT05357846
Study groupRoleWhat they receive
NCRT+IO groupExperimental• NCRT+IO group consists of the PD-1 inhibitor combined with concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks.PD-1 inhibitor is given by intravenous infusion on days 1 and 22. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22. Interventions: * Radiation: (40 or 45 Gy/20 fractions) * Drug: Sintilimab * Drug: Paclitaxel * Drug: Cisplatin
Receives: Drug: Sintilimab; Radiation: Preoperative radiotherapy; Drug: Paclitaxel; Drug: Cisplatin; Procedure: esophagectomy
NCRT groupActive comparator• NCRT group consists of the concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22. Interventions: * Radiation: (40 or 45 Gy/20 fractions) * Drug: Paclitaxel * Drug: Cisplatin
Receives: Radiation: Preoperative radiotherapy; Drug: Paclitaxel; Drug: Cisplatin; Procedure: esophagectomy

What is being measured

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

  1. Overall survival

    Overall survival will be calculated from the date of randomization and an event registered on the date of death from any cause. Patients lost to follow up, or those with no death recorded on the day the database is frozen, will be censored on the date of last follow up.

    Measured: At end of enrollment- up to 5 years in follow up

Secondary outcomes (5)

  1. Progression free survival

    Progression free survival is defined as the time from randomization until objective tumor progression or death.

    Measured: At end of enrollment- up to 5 years in follow up

  2. Pathologic complete response rate

    No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes

    Measured: Two weeks after surgery

  3. R0 resection rate

    The percentage of patients who undergo complete resection

    Measured: Two weeks after surgery

  4. Incidence of perioperative complications

    Incidence of complications

    Measured: Ninety days after surgery

  5. Perioperative mortality

    Incidence of death postoperatively

    Measured: Ninety 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 posted3 May 2022
  2. Study start1 Nov 2022
  3. Primary completion1 Jan 2031 (estimated)
  4. Study completion31 Jan 2031 (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
422 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05357846
Sponsor's protocol ID
NEOCRTEC2101
Status last verified
Apr 2026
First submitted
22 Mar 2022
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sintilimab, Preoperative radiotherapy and Paclitaxel in people with Squamous Cell Esophageal Carcinoma and Esophageal Cancer, run by Sun Yat-sen 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 14 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 30 Apr 2026. 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 HONG YANG, M.D. Ph.D. (8602087343 ext. 8602087343, yanghong@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: At end of enrollment- up to 5 years in follow up). 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 NCT05357846.

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 30 Apr 2026.

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