Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Neoadjuvant Immunotherapy Plus Chemotherapy and Anlotinib Versus Immunotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced ESCC

A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (NCT06354530) is a Phase 2 / Phase 3 interventional studying Neoadjuvant Therapy and Esophageal Squamous Cell Carcinoma, sponsored by Army Medical Center of PLA. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Neoadjuvant Therapy 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 266 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Neoadjuvant Therapy 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: - Surgically resectable cT1-4aN+M0 or cT3-4aN0M0 esophageal squamous cell carcinoma initially diagnosed by histology or cytology - Patients who can take anlotinib capsules orally - No previous systematic antitumor treatment - ECOG PS 0-1 - The function of important organs meets the following requirements: absolute neutrophil count≥1.5×10\^9 / L; platelet count at least 80×10\^9 / L; blood count (hemoglobin) at least 80×10\^9 / L; total bilirubin≤1.5×upper limit of normal; within normal serum creatinine; ALT and glutamatergic aminase≤2.5× upper limit of normal - No incurable serious complications or other major diseases - The thoracic surgeon judges that the operation can be tolerated - Female subjects with fertility, and male subjects with childbearing partners, required a medically approved contraceptive during study treatment and at least 6 months after the last chemotherapy - The subjects volunteered to join the study, signed willing to sign a consent form, had good compliance and cooperated with follow-up Who Should NOT Join This Trial: - BMI\<18.5kg/m2 or 10% weight loss in 2 months before screening (while considering the effect of large chest ascites on body weight) - Patients with tracheal / bronchial / macrovascular invasion, deep ulcer esophagus, digestive tract perforation and / or fistula, major bleeding, and poor lung function or previous chronic lung disease within 6 months prior to initial medication - Patients with significant feeding obstruction unable to take oral anlotinib - Known history of allergy to any component of biological or PD-1 mab formulation, albumin-bound paclitaxel, carboplatin and other platinum drugs manufactured by Chinese hamster ovary cells (CHO) - Have received any of the following treatments: any investigational drug; enrolled in another clinical study except for an observational (non-interventional) clinical study; received anti-tumor or live vaccine ...See full criteria on ClinicalTrials.gov 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: * Surgically resectable cT1-4aN+M0 or cT3-4aN0M0 esophageal squamous cell carcinoma initially diagnosed by histology or cytology * Patients who can take anlotinib capsules orally * No previous systematic antitumor treatment * ECOG PS 0-1 * The function of important organs meets the following requirements: absolute neutrophil count≥1.5×10\^9 / L; platelet≥80×10\^9 / L; hemoglobin≥80×10\^9 / L; total bilirubin≤1.5×upper limit of normal; within normal serum creatinine; ALT and glutamatergic aminase≤2.5× upper limit of normal * No incurable serious complications or other major diseases * The thoracic surgeon judges that the operation can be tolerated * Female subjects with fertility, and male subjects with childbearing partners, required a medically approved contraceptive during study treatment and at least 6 months after the last chemotherapy * The subjects volunteered to join the study, signed informed consent, had good compliance and cooperated with follow-up Exclusion Criteria: * BMI\<18.5kg/m2 or 10% weight loss in 2 months before screening (while considering the effect of large chest ascites on body weight) * Patients with tracheal / bronchial / macrovascular invasion, deep ulcer esophagus, digestive tract perforation and / or fistula, major bleeding, and poor lung function or previous chronic lung disease within 6 months prior to initial medication * Patients with significant feeding obstruction unable to take oral anlotinib * Known history of allergy to any component of biological or PD-1 mab formulation, albumin-bound paclitaxel, carboplatin and other platinum drugs manufactured by Chinese hamster ovary cells (CHO) * Have received any of the following treatments: any investigational drug; enrolled in another clinical study except for an observational (non-interventional) clinical study; received anti-tumor or live vaccine * A history of active autoimmune diseases and autoimmune diseases * A history of immunodeficiency, including a positive HIV test, or other acquired, congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation * The subject had cardiovascular clinical symptoms or disease that were not well controlled * Patients with active hepatitis B or hepatitis C and active pulmonary tuberculosis * Severe infection (CTCAE\> 2) occurred within 4 weeks prior to initial use of study drug, such as severe pneumonia, bacteremia, infection requiring hospitalization; baseline chest imaging indicated active lung inflammation, symptoms and signs of infection within 2 weeks prior to initial use of study drug or the need for oral or intravenous antibiotics, except for prophylactic antibiotics * Major surgery (except diagnostic surgery) within 28 days prior to treatment, or is expected to undergo major surgery during the study * Any other malignancy had been diagnosed within 5 years prior to the first use of study drug, except for nausea tumors with low risk and mortality (5-year survival\> 90%), such as adequately treated basal or squamous cell skin carcinoma or carcinoma of the cervix * Female patients during pregnancy or lactation and who were refused or unable to use contraception * At the discretion of the investigator, the subject had other factors that could contribute to his forced termination

Treatments Being Tested

DRUG

anlotinib

Drug: Camrelizumab 200mg on Day 1 of each 3-week cycle for 2 cycles during the neoadjuvant period Drug: Carboplatin Area under the curve of 5 on Day 1 of each 3-week cycle for 2 cycles Drug: Cisplatin 75 mg/m2 on Day 1 of each 3-week cycle, for 2 cycles Drug: Paclitaxel 135-175 mg/m2 on Day 1 of each 3-week cycle for 2 cycles Drug: Nab-Paclitaxel 220-260 mg/m2 on Day 1 of each 3-week cycle for 2 cycles Drug: anlotinib 8 mg/day orally (from days 1 to 14 in a 21-day cycle) for 2 cycles

RADIATION

Thoracic radiotherapy

Drug: Camrelizumab 200mg on Day 1 of each 3-week cycle for 2 cycles during the neoadjuvant period Drug: Carboplatin Area under the curve of 5 on Day 1 of each 3-week cycle for 2 cycles Drug: Cisplatin 75 mg/m2 on Day 1 of each 3-week cycle, for 2 cycles Drug: Paclitaxel 135-175 mg/m2 on Day 1 of each 3-week cycle for 2 cycles Drug: Nab-Paclitaxel 220-260 mg/m2 on Day 1 of each 3-week cycle for 2 cycles Thoracic radiotherapy RT once daily (from cycle 1 \[C1D1\], 41.4Gy/23Fx, 1.8Gy daily, for 4.6 weeks, 5 days/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.

Army Medical Center of PLA
Chongqing, None Selected, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06354530), the sponsor (Army Medical Center of PLA), 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 NCT06354530 clinical trial studying?

The goal of this interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant trea… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06354530?

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 NCT06354530?

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 NCT06354530. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06354530. 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.