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Esophageal Squamous Cell Carcinoma (ESCC)Phase 3ESCCNCT06775652

Neoadjuvant Chemoradiotherapy Plus Surgery vs. Surgery Plus Adjuvant Therapy for ESCC

A Phase 3 study testing Neoadjuvant Chemoradiotherapy, Adjuvant therapy and Surgery in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Yongtao Han 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

This phase III randomized clinical trial compared the long-term survival and safety of neoadjuvant chemoradiotherapy (NCRT) followed by surgery versus surgery with adjuvant therapy (AT) in patients with locally advanced esophageal squamous cell carcinoma (ESCC). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Neoadjuvant Chemoradiotherapy, Adjuvant therapy and Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
254 participants
Where
1 siteChina
Study dates
1 Jan 2018to 31 Jul 2024
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Aged 18 to 75 years, both sexes; 2. Histologically confirmed locally advanced (cT1N+M0 or T2-4aNxM0) thoracic esophageal squamous cell carcinoma (8th UICC-TNM stage); 3. Cervical contrast-enhanced CT showed no suspicious metastatic lymph nodes, and imaging studies confirmed no systemic metastasis; 4. Expected to achieve R0 resection; 5. ECOG performance status 0 to 1; 6. No prior antitumor therapy for esophageal cancer, including chemotherapy, radiotherapy (including planned radiotherapy during the study), hormone therapy, or immunotherapy; 7. Measurable lesions according to RECIST v1.1 criteria; 8. No contraindications for surgery based on preoperative evaluation of organ function; 9. Laboratory test results confirm eligibility:
  • Hemoglobin ≥90 g/L;
  • White blood cell count ≥ the laboratory lower limit of normal;
  • Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
  • Platelet count ≥100×10⁹/L;
  • Total bilirubin ≤1.5× upper limit of normal (ULN);
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  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN;
  • Prothrombin time ≤16 seconds and international normalized ratio (INR) ≤1.5× ULN;
  • Serum creatinine ≤1.5× ULN or creatinine clearance ≥50 mL/min (calculated using the Cockcroft-Gault formula); 10. Women of childbearing potential must agree to use effective contraception (e.g., intrauterine devices, oral contraceptives, or condoms) during the study medication period and for 60 days after the last dose, have a negative serum pregnancy test within 7 days prior to enrollment, and must not be lactating; 11. Men must agree to use effective contraception during the study medication period and for 60 days after the last dose; 12. Participants must understand and sign the informed consent form.

Who cannot join

  • 1. History of Other Malignancies: 1.1. Patients who have had malignancies other than esophageal cancer.
  • 2. Bleeding Tendency and Coagulation Disorders: 2.1. Gastrointestinal bleeding within 6 months prior to randomization. 2.2. Coagulation disorders at the time of enrollment. 2.3. Patients receiving thrombolysis or anticoagulant therapy.
  • 3. Cardiovascular and Cerebrovascular Diseases: 3.1. The following conditions within 12 months prior to randomization:
  • Congestive heart failure classified as NYHA class II or higher.
  • Unstable angina, myocardial infarction, or poorly controlled arrhythmias.
  • Cerebrovascular accidents. 3.2. Left ventricular ejection fraction (LVEF) <50% on echocardiography. 3.3. Corrected QT interval (QTc) >480 ms (calculated using the Fridericia formula; if QTc is abnormal, three consecutive tests should be conducted at 2-minute intervals, and the average value used).
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  • 3.4. Medically difficult-to-control hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg) based on the average of at least two measurements.
  • 3.5. History of hypertensive crises or hypertensive encephalopathy.
  • 4. Respiratory Diseases: 4.1. History of interstitial lung disease or pneumonia requiring steroid treatment at enrollment.
  • 4.2. Active tuberculosis at the time of randomization or anti-tuberculosis treatment within 1 year prior to randomization.
  • 4.3. Asthma requiring intermittent bronchodilators or other medical interventions at randomization.
  • 5. Infectious and Inflammatory Diseases: 5.1. Patients with active hepatitis B must receive effective treatment before enrollment.
  • 5.2. For patients positive for HCV antibodies, HCV-RNA testing should exclude those with HCV-RNA >10³ copies/mL.
  • 5.3. Co-infection with HIV.
  • 6. Surgery-Related Risks: 6.1. Severe unhealed wounds, active ulcers, or untreated fractures at the time of randomization.
  • 6.2. Other conditions rendering the patient inoperable. 6.3. Prior surgeries that preclude using the stomach for esophageal reconstruction during this surgery.
  • 7. Drug and Treatment-Related Risks: 7.1. Receiving systemic steroid therapy (daily prednisone >10 mg or equivalent) or other immunosuppressive agents within 2 weeks before randomization.
  • 7.2. Severe allergy to chemotherapy drugs. 7.3. Previous organ transplant recipients.
  • 8. Liver Function Requirements: 8.1. For patients with HBsAg(+) and/or HBcAb(+), HBV DNA must be <500 IU/mL with normal liver function.
  • 8.2. Continued effective anti-HBV therapy during the study or initiation of entecavir or tenofovir treatment prior to study medication.
  • 9. Other Conditions: 9.1. Severe unhealed wounds, active ulcers, or untreated fractures at the time of randomization.
  • 9.2. Any condition deemed unsuitable for study participation by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sichuan Cancer Hospital and Institute

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: Neoadjuvant Chemoradiotherapy Plus Surgery vs. Surgery Plus Adjuvant Therapy for Esophageal Squamous Cell Carcinoma: A Prospective, Randomized Phase III Clinical Trial

This phase III randomized clinical trial compared the long-term survival and safety of neoadjuvant chemoradiotherapy (NCRT) followed by surgery versus surgery with adjuvant therapy (AT) in patients with locally advanced esophageal squamous cell carcinoma (ESCC). Conducted at Sichuan Cancer Hospital, patients were randomly assigned to receive either NCRT (chemotherapy and radiotherapy followed by surgery) or AT (surgery followed by adjuvant therapy based on staging).

The primary outcome was overall survival (OS), with secondary outcomes including disease-free survival (DFS), R0 resection rates, and treatment-related toxicity. A total of 245 patients were randomized, and 224 patients were included in the final analysis.

Read the detailed description

This study is a prospective, randomized, open-label, phase III clinical trial conducted at Sichuan Cancer Hospital, a high-volume cancer center in China. The primary objective is to compare the long-term survival outcomes of neoadjuvant chemoradiotherapy (NCRT) combined with surgery versus surgery followed by adjuvant therapy (AT) in patients with locally advanced esophageal squamous cell carcinoma (ESCC).

Patients with histologically confirmed, resectable, locally advanced thoracic ESCC (staged according to the 8th edition of the AJCC TNM classification) were enrolled and randomized in a 1:1 ratio to the NCRT or AT group. The NCRT group received intensity-modulated radiotherapy (40 Gy in 20 fractions) combined with paclitaxel and carboplatin, followed by surgery. The AT group underwent surgery first, followed by adjuvant therapy (chemotherapy or chemoradiotherapy) determined by postoperative pathological staging based on the 2018 NCCN Guidelines for Esophageal and Esophagogastric Junction Cancers.

The study's primary endpoint is overall survival (OS). Secondary endpoints include disease-free survival (DFS), R0 resection rate, pathological complete response (pCR) rate, treatment-related toxicity, and postoperative complications. Safety was assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) and the Clavien-Dindo classification for surgical complications.

A total of 245 patients were randomized, with 116 patients in the NCRT group and 108 in the AT group achieving R0 resection and included in the final analysis. Kaplan-Meier survival analysis and Cox proportional hazards models were employed to evaluate OS and DFS.

This trial seeks to provide high-quality evidence for optimizing treatment strategies in locally advanced ESCC and to highlight the significance of achieving pathological response as a predictor of improved survival. Future studies with larger sample sizes and multi-center participation are needed to validate these findings.

Being tested
Neoadjuvant Chemoradiotherapy, Adjuvant therapy, Surgery
Keywords
Esophageal squamous cell carcinoma, Neoadjuvant chemoradiotherapy, Adjuvant therapy, Overall survival, Pathological complete response
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.

  • Neoadjuvant ChemoradiotherapyDrug

    Patients assigned to the NCRT group received intravenous paclitaxel (135 mg/m²) and carboplatin (AUC=2-5) on day 1, administered every three weeks for two cycles. Concurrently, they received intensity-modulated radiotherapy (IMRT) with a total of 20 sessions (CTV 40 Gy, GTV 44 Gy) five days per week. All radiotherapy plans were reviewed by designated radiation oncologists before treatment to ensure quality control. Patients were assessed 4 to 6 weeks after completing NCRT following RECIST 1.1 criteria.

  • Adjuvant therapyProcedure or surgery

    Patients in the AT group received surgery as soon as possible after randomization, followed by adjuvant therapy, postoperative adjuvant therapy based on pathological staging, as recommended by the NCCN Clinical Practice Guidelines for Esophageal and Esophagogastric Junction Cancers (2017 V4), starting one month post-surgery with either adjuvant chemotherapy or chemoradiotherapy. The adjuvant chemotherapy regimen was the same as the neoadjuvant chemotherapy regimen, and the adjuvant radiotherapy regimen and dose were administered according to guideline recommendations.

  • SurgeryProcedure or surgery

    Surgery

Study groups in NCT06775652
Study groupRoleWhat they receive
NCRT groupExperimentalNot described
Receives: Drug: Neoadjuvant Chemoradiotherapy; Procedure: Surgery
AT groupActive comparatorNot described
Receives: Procedure: Adjuvant therapy; Procedure: Surgery

What is being measured

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

  1. OS

    Overall survival

    Measured: 5 years

Secondary outcomes (4)

  1. DFS

    Disease-free survival

    Measured: 5 years

  2. Adverse Events

    Treatment-related toxicity, postoperative complications

    Measured: 1 years

  3. R0 resection rate

    Other outcomes

    Measured: 1 years

  4. pathological complete response (pCR) rate

    Other outcomes

    Measured: 1 years

Timeline

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

  1. First posted15 Jan 2025
  2. Study start1 Jan 2018
  3. Primary completion31 Dec 2020
  4. Study completion31 Jul 2024

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
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06775652
Sponsor's protocol ID
SCCH-TS1801
Acronym
ESCC
Status last verified
Jan 2025
First submitted
9 Jan 2025
Last updated
15 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: This study aims to compare the long-term survival outcomes and safety profiles of neoadjuvant chemoradiotherapy (NCRT) followed by surgery versus surgery with adjuvant therapy (AT) in patients with locally advanced esophageal squamous cell carcinoma (ESCC). The study follows a prospective, randomized, open-label, phase III clinical trial design. Eligible patients were assigned in a 1:1 ratio to receive either NCRT followed by surgery or surgery with AT, with treatment assignments stratified by a permuted-block randomization method. Key endpoints include overall survival (OS), disease-free survival (DFS), pathological outcomes, and treatment-related adverse events. This research emphasizes the importance of pathological complete response (pCR) as a predictor of improved survival and aims to provide robust evidence to guide treatment strategies for locally advanced ESCC. Data collection, patient follow-up, and statistical analyses were conducted in accordance with international clinical

Publications

  • He W, Li Z, Xie Q, Han Y, Peng L, Wang C, Wang K, Liu G, Li H, Zhou Q, Li J, Zhang H, Xiao W, Fang Q, Miao Y, Leng X. Long-Term Survival Outcomes of NCRT With Surgery vs Surgery With Adjuvant Therapy for ESCC: A Single-Center Prospective Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2550307. doi: 10.1001/jamanetworkopen.2025.50307.

    PubMed 41490111

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neoadjuvant Chemoradiotherapy, Adjuvant therapy and Surgery in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Yongtao Han 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 9 inclusion and 22 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 15 Jan 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 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?

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?

OS (time frame: 5 years). 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 NCT06775652, 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 15 Jan 2025.

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