Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma

Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study

Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma (NCT06907602) is a Phase 2 / Phase 3 interventional studying Locally Advanced Esophageal Squamous Cell Carcinoma, sponsored by Peking Union Medical College Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. The results show that the pathological complete response rate (pCR) reaches 35%, and the major pathological response rate is over 70%, which is much higher than that of patients receiving chemotherapy alone. Meanwhile, no severe adverse drug reactions have been found in terms of safety, so this treatment regimen is safe and reliable. However, the cycle of neoadjuvant immunotherapy is still under exploration. Currently, the mainstream research centers adopt a regimen of 2 to 4 cycles. The exploration results of our center have found that most patients' conditions can be further alleviated after 4 cycles compared with after 2 cycles, but there are still a small number of patients with no obvious remission. Therefore, we consider observing whether patients with no obvious remission can achieve a better pathological response rate through further radiotherapy.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Locally Advanced Esophageal Squamous Cell Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA 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.

Target enrollment of 120 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Locally Advanced Esophageal Squamous Cell Carcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - male or female - Age ≥ 18 years old - Pathological confirmation of esophageal squamous cell carcinoma - Endoscopic ultrasound, enhanced CT scan of the neck, chest, and abdomen, and esophageal magnetic resonance imaging evaluate as T3 or resectable T4 PET/CT、 Cervical, thoracic, and abdominal enhanced CT evaluation of N0 or N+ - No clear distant metastasis (M0) and only cervical or supraclavicular lymph node metastasis (M1a) - Tumor longitudinal diameter ≤ 10cm - The tumor did not involve the dentate line - ECOG score 0 or 1 - No hematological diseases, no liver or kidney dysfunction - Absolute neutrophil count ≥ 1.5 × 109/L - platelet count at least 100 × 109/L - blood count (hemoglobin) at least 11g/L - ALT ≤ 2 times the upper limit of normal value - TBil ≤ 1.5 times the upper limit of normal value - Creatinine clearance rate (Cockroft) ≥ 50ml/min - Obtain willing to sign a consent form Who Should NOT Join This Trial: - T staging evaluation is T1/T2 - PET/CT and other evaluations show distant metastasis (M1) - Planned pregnancy or patients during pregnancy or lactation - History of previous chemotherapy, radiation therapy, or immunotherapy - Previous severe coronary heart disease and heart failure (NYHA grade III/IV) - Previous pulmonary interstitial fibrosis or severe pulmonary dysfunction that cannot tolerate surgery - Previous autoimmune conditions (where your immune system attacks your own body) requiring systemic treatment within 2 years - Previous weakened immune system diseases or the need for systemic steroid replacement therapy - Previous motor or sensory neurotoxic diseases - Previous mental illness - Potential diseases that may affect patients' ability to receive planned treatment, such as drug allergies - Acute infectious diseases requiring systemic treatment - Previous HIV, HBV, or HCV infections - Previously received stem cell or solid organ transplantation 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: * male or female * Age ≥ 18 years old * Pathological confirmation of esophageal squamous cell carcinoma * Endoscopic ultrasound, enhanced CT scan of the neck, chest, and abdomen, and esophageal magnetic resonance imaging evaluate as T3 or resectable T4 PET/CT、 Cervical, thoracic, and abdominal enhanced CT evaluation of N0 or N+ * No clear distant metastasis (M0) and only cervical or supraclavicular lymph node metastasis (M1a) * Tumor longitudinal diameter ≤ 10cm * The tumor did not involve the dentate line * ECOG score 0 or 1 * No hematological diseases, no liver or kidney dysfunction * Absolute neutrophil count ≥ 1.5 × 109/L * Platelets ≥ 100 × 109/L * Hemoglobin ≥ 11g/L * ALT ≤ 2 times the upper limit of normal value * TBil ≤ 1.5 times the upper limit of normal value * Creatinine clearance rate (Cockroft) ≥ 50ml/min * Obtain informed consent Exclusion Criteria: * T staging evaluation is T1/T2 * PET/CT and other evaluations show distant metastasis (M1) * Planned pregnancy or patients during pregnancy or lactation * History of previous chemotherapy, radiation therapy, or immunotherapy * Previous severe coronary heart disease and heart failure (NYHA grade III/IV) * Previous pulmonary interstitial fibrosis or severe pulmonary dysfunction that cannot tolerate surgery * Previous autoimmune disease requiring systemic treatment within 2 years * Previous immunodeficiency diseases or the need for systemic steroid replacement therapy * Previous motor or sensory neurotoxic diseases * Previous mental illness * Potential diseases that may affect patients' ability to receive planned treatment, such as drug allergies * Acute infectious diseases requiring systemic treatment * Previous HIV, HBV, or HCV infections * Previously received stem cell or solid organ transplantation

Treatments Being Tested

DRUG

Chemotherapy

carboplatin plus nab-paclitaxel

DRUG

Immunotherapy (Pembrolizumab)

Pembrolizumab

RADIATION

radiotherapy

40-45Gy/20fx，5 times a week

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.

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06907602), the sponsor (Peking Union Medical College 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 NCT06907602 clinical trial studying?

Who can participate in NCT06907602?

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 NCT06907602?

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 NCT06907602. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06907602. 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.