Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma

Multicenter Prospective Randomized Controlled Study of Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone in the Treatment of pN1-2 (pT1b-3N1-2M0) Thoracic Esophageal Squamous Cell Carcinoma

Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma (NCT04009265) is a Phase 3 interventional studying Esophageal Squamous Cell Carcinoma, sponsored by Fujian Medical University Union Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone for the patients with esophageal cancer.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Esophageal Squamous Cell Carcinoma, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 819 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participants volunteer to participate the study and signed the willing to sign a consent form. 2. Surgical methods: Radical resection of tumors (R0) was performed, and pathological examination confirmed the diagnosis of thoracic esophageal squamous cell carcinoma. 3. No antineoplastic treatments before operation. 4. According to the 8th edition of AJCC staging, pN1-2 (pT1b-3N1-2M0) stage of esophageal cancer; 5. WHO PS score: 0-1; 6. Age and gender: 18-75 years old, male and female unlimited; 7. Laboratory examination within one week before the adjuvant treatment confirmed that the cardiac, hepatic and renal functions met the requirements. Who Should NOT Join This Trial: 1. The surgical approach is left thoracic approach; 2. Patients with severe postoperative complications who cannot receive adjuvant therapy; 3. Received other anti-tumor treatment before enrollment; At the same time, patients with malignant tumors of other sites were excluded, except non-melanoma skin cancer, in-situ cervical cancer or cured early prostate cancer. 4. Abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment; 5. Patients with original severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction within half a year, severe heart valve disease and intractable hypertension; Severe hepatic and renal insufficiency; 6. Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response; 7. Known or suspected allergy to chemotherapeutic drugs. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Participants volunteer to participate the study and signed the informed consent. 2. Surgical methods: Radical resection of tumors (R0) was performed, and pathological examination confirmed the diagnosis of thoracic esophageal squamous cell carcinoma. 3. No antineoplastic treatments before operation. 4. According to the 8th edition of AJCC staging, pN1-2 (pT1b-3N1-2M0) stage of esophageal cancer; 5. WHO PS score: 0-1; 6. Age and gender: 18-75 years old, male and female unlimited; 7. Laboratory examination within one week before the adjuvant treatment confirmed that the cardiac, hepatic and renal functions met the requirements. Exclusion Criteria: 1. The surgical approach is left thoracic approach; 2. Patients with severe postoperative complications who cannot receive adjuvant therapy; 3. Received other anti-tumor treatment before enrollment; At the same time, patients with malignant tumors of other sites were excluded, except non-melanoma skin cancer, in-situ cervical cancer or cured early prostate cancer. 4. Abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment; 5. Patients with original severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction within half a year, severe heart valve disease and intractable hypertension; Severe hepatic and renal insufficiency; 6. Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response; 7. Known or suspected allergy to chemotherapeutic drugs.

Treatments Being Tested

COMBINATION_PRODUCT

adjuvant treatment

adjuvant treatments include chemotherapy or chemoradiotherapy

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04009265), the sponsor (Fujian Medical University Union Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04009265 clinical trial studying?

A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone for the patients with esophageal cancer. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04009265?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04009265?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04009265. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04009265. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.