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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.

Prospective Single-arm, Exploratory, Multicenter Phase II Clinical Study of Camrelizumab Combined With Chemoradiotherapy in the Treatment of Advanced First-line Esophageal Phosphorous Carcinoma

Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer. (NCT05624099) is a Phase 2 interventional studying Esophageal Neoplasms and Esophageal Diseases, sponsored by Fujian Cancer Hospital. 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

This is a prospective single-arm exploratory clinical study. The efficacy and safety of camrelizumab combined with chemoradiotherapy and camrelizumab combined with chemotherapy were evaluated in patients with advanced esophageal cancer who had not previously received any systemic antitumor therapy for esophageal cancer.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Esophageal Neoplasms 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 75 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Esophageal Neoplasms 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: 1. Sign written willing to sign a consent form and voluntarily participate in this study; 2. Patients with esophageal squamous cell carcinoma confirmed by histopathology and/or immunohistochemistry (8th edition 2017) had UICC/AJCC TNM stage IVA or oligometastatic stage IVB; 3. Survival is expected to exceed 3 months 4. Age 18-75; 5. ECOG PS 0-2 6. Never received any systemic anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, targeted and immunotherapy; 7. Have at least one measurable lesion 8. Normal function of major organs, including: 1. Routine blood test (no blood components, cell growth factors, whitening drugs, platelet raising drugs, and anemia correcting drugs are allowed within 14 days before the first use of study drugs) White blood cell count ≥ 3.0×10\^9/L Neutrophil count ≥ 1.0×10\^9/L Platelet count ≥ 80×109/L blood count (hemoglobin) at least 80 g/L 2. Blood biochemical examination: Total bilirubin ≤ 1.5×ULN ALT ≤2.5×ULN, AST ≤2.5×ULN, Serum creatinine ≤ 1.5×ULN, or kidney function (creatinine clearance) at least 45mL/min 9. Subjects have good compliance and cooperate with follow-up Who Should NOT Join This Trial: 1. The presence of uncontrollable pleural effusion, pericardial effusion or ascites that require repeated drainage; 2. Poor nutritional status, BMI \< 18.5 Kg/m\^2; If symptomatic nutritional support was corrected before randomization, enrollment could be considered after evaluation by the principal investigator; 3. Gastrointestinal bleeding (bleeding volume \> 200ml/ day); 4. Patients with deep ulcers as determined by the investigator; 5. Previous allergy to monoclonal antibodies, any component of camrelizumab, paclitaxel, cisplatin or other platinum-based drugs; 6. Has received or is receiving any of the following medical treatment: 1. any radiation, chemotherapy or other antitumor drugs for the tumor; ...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: 1. Sign written informed consent and voluntarily participate in this study; 2. Patients with esophageal squamous cell carcinoma confirmed by histopathology and/or immunohistochemistry (8th edition 2017) had UICC/AJCC TNM stage IVA or oligometastatic stage IVB; 3. Survival is expected to exceed 3 months 4. Age 18-75; 5. ECOG PS 0-2 6. Never received any systemic anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, targeted and immunotherapy; 7. Have at least one measurable lesion 8. Normal function of major organs, including: 1. Routine blood test (no blood components, cell growth factors, whitening drugs, platelet raising drugs, and anemia correcting drugs are allowed within 14 days before the first use of study drugs) White blood cell count ≥ 3.0×10\^9/L Neutrophil count ≥ 1.0×10\^9/L Platelet count ≥ 80×109/L Hemoglobin ≥ 80 g/L 2. Blood biochemical examination: Total bilirubin ≤ 1.5×ULN ALT ≤2.5×ULN, AST ≤2.5×ULN, Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 45mL/min 9. Subjects have good compliance and cooperate with follow-up Exclusion Criteria: 1. The presence of uncontrollable pleural effusion, pericardial effusion or ascites that require repeated drainage; 2. Poor nutritional status, BMI \< 18.5 Kg/m\^2; If symptomatic nutritional support was corrected before randomization, enrollment could be considered after evaluation by the principal investigator; 3. Gastrointestinal bleeding (bleeding volume \> 200ml/ day); 4. Patients with deep ulcers as determined by the investigator; 5. Previous allergy to monoclonal antibodies, any component of camrelizumab, paclitaxel, cisplatin or other platinum-based drugs; 6. Has received or is receiving any of the following medical treatment: 1. any radiation, chemotherapy or other antitumor drugs for the tumor; 2. Being treated with immunosuppressive agents or systemic hormones for immunosuppression purposes (dose \>10mg/ day prednisone or equivalent) within 2 weeks prior to the first use of the study drug; In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at a dose of \>10mg/ day or its equivalent are permitted; 3. Received live attenuated vaccine within 4 weeks before the first administration of the study drug; 4. Major surgery or severe trauma within 4 weeks before the first use of the study drug; 7. A history of any active autoimmune disease or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (which may be considered for inclusion after hormone replacement therapy); Patients with complete remission of psoriasis or childhood asthma/allergies who did not require any intervention as adults were considered for inclusion, but patients requiring medical intervention with bronchodilators were not included; 8. A history of immunodeficiency, including being HIV positive, or suffering from another acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation; 9. The presence of poorly controlled cardiac clinical symptoms or diseases, including but not limited to: Such as (1) NYHAII grade or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias are not well controlled without clinical intervention or after clinical intervention; 10. Severe infection (CTCAE \> 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications requiring hospitalization; Baseline chest imaging examination indicated active pulmonary inflammation, signs and symptoms of infection within 14 days before the first use of study drugs, or the need for oral or intravenous antibiotic treatment, except for prophylactic antibiotic use; 11. Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year ago but without regular treatment; 12. The presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL) and hepatitis C (HCV antibody positive and HCV RNA above the assay limit); 13. In the judgment of the investigator, there are other factors that may lead to the forced termination of the study, such as the presence of other serious medical conditions (including mental illness) requiring concomitant treatment, alcoholism, substance abuse, family or social factors, and factors that may affect the safety or compliance of the subjects.

Treatments Being Tested

DRUG

camrelizumab

200mg intravenous drip d1q3w

DRUG

Paclitaxel drugs

150mg/m2 d1 q3w

DRUG

Platinum drug

Cisplatin, carboplatin, nedaplatin and other platinum drugs

RADIATION

Radiation

Dose: 5040cGy/28f

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 Cancer Hospital
Fuzhou, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05624099), the sponsor (Fujian Cancer 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 NCT05624099 clinical trial studying?

This is a prospective single-arm exploratory clinical study. The efficacy and safety of camrelizumab combined with chemoradiotherapy and camrelizumab combined with chemotherapy were evaluated in patients with advanced esophageal cancer who had not previously received any systemic antitumor therapy for 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 NCT05624099?

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 NCT05624099?

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 NCT05624099. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05624099. 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.