Clinical trial · Interventional

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

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)

NCT05357846CI-TRIAL-00109893recruitingPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Esophageal Cancer	Malignant Esophageal Neoplasm	CURATED_EXACT	0.92
Oesophageal Cancer	—	UNRESOLVED	—
Squamous Cell Esophageal Carcinoma	—	UNRESOLVED	—

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Cisplatin	Drug	Cisplatin	ALIAS
esophagectomy	Procedure	—	UNRESOLVED
Paclitaxel	Drug	Paclitaxel	ALIAS
Preoperative radiotherapy	Radiation	—	UNRESOLVED
Sintilimab	Drug	Sintilimab	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
NCRT+IO group
description
• 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
interventionNames
1. Drug: Sintilimab
2. Radiation: Preoperative radiotherapy
3. Drug: Paclitaxel
4. Drug: Cisplatin
5. Procedure: esophagectomy
type
ACTIVE_COMPARATOR
label
NCRT group
description
• 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

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.
2. Patients must not have received any prior anticancer therapy.
3. More than 6 months of expected survival.
4. Age ranges from 18 to 70 years.
5. 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.
6. WHO PS score 0-1
7. Signed informed consent document on file.

Exclusion Criteria:

1. Patients have received any prior anticancer therapy.
2. Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.
3. Patients with concomitant hemorrhagic disease.
4. Patients who cannot tolerate surgery.
5. Pregnant or breast feeding.
6. Patients without informed consent because of psychological, family, social or any other factors.
7. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
8. Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
9. Patients with history of diabetes over 10 years and unsatisfactory glycemic control.
10. 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.
11. Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation.
12. Patients with history of interstitial lung disease or noninfectious pneumonia.
13. 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.
14. Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Nov 1, 2022
Primary completion: Jan 1, 2031
Completion: Jan 31, 2031
First posted: May 3, 2022
Last update posted: Apr 30, 2026
Enrollment: 422 (estimated)
Lead sponsor: Sun Yat-sen University OTHER
Collaborators: Affiliated Cancer Hospital of Shantou University Medical College

Data updated 22 days agoSource updated Apr 30, 2026source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
China	1	1

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.