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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study of Perioperative Camrelizumab Combined With Chemotherapy in Patients With Resectable ESCC

A Randomized, Controlled, Phase II Study of Perioperative Camrelizumab Combined With Albumin Paclitaxel and Cisplatin in Patients With Resectable Esophageal Squamous Cell Carcinoma

A Study of Perioperative Camrelizumab Combined With Chemotherapy in Patients With Resectable ESCC (NCT05182944) is a Phase 2 interventional studying Esophageal Cancer, sponsored by The First Affiliated Hospital of Zhengzhou University. 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 purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Esophageal Cancer 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 130 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Esophageal Cancer 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. Aged 18-80 years, males or females; 2. diagnosed by tissue sample (biopsy-confirmed) as ESCC; 3. Esophageal squamous cell carcinoma without anti-tumor treatment, and the clinical stage is T1b-2N+M0 or T3-4aN+/-M0 (AJCC/UICC TNM staging system 8th edition); 4. It can provide tumor tissue for the detection of PD-L1 expression level; 5. Follow-up surgery plan: radical esophageal squamous cell carcinoma surgery with esophagogastric reconstruction combined with at least complete 2 field lymph node dissection; 6. ECOG: 0\~1; 7. Expected survival time ≥ 12 weeks; 8. Body mass index (BMI) ≥ 18.5kg/m2 or pg-sga score A / B; 9. 1)White blood cell count (WBC) ≥3.0 × 109/L, absolute neutrophil count (ANC) ≥1.5 × 109/L, platelet (PLT) count ≥100×109/L, hemoglobin (HGB) ≥90 g/L, No blood transfusion or other hematopoietic factor treatment for the previous 14 days; 2)Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5×upper limit of normal (ULN); serum total bilirubin (TBIL) ≤1.5×ULN ; Albumin (ALB) ≥30g/L; 3)Serum creatinine (CRE)≤1.0×ULN, creatinine clearance (Ccr)≥60 mL/min (Cockcroft-Gault formula); 4)International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) ≤ 1.5 × ULN; 10. Important organ functions: a) Heart function: normal or grade I; b) Lung function: FEV1\>1.2L, FEV1% \>40%; c) Liver function: Child-Pugh grade 5-6 points; 11. For premenopausal women (postmenopausal women must have been postmenopausal for at least 12 months to be considered infertile), the serum pregnancy test result is negative. Male subjects (including male subjects' female spouses of childbearing age) and female subjects of childbearing age must contraception from the first study drug administration to 6 months after the last study drug administration; 12. Obtain the willing to sign a consent form signed by the subject or his legal representative; 13. Can cooperate to complete research procedures and follow-up inspections。 ...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. Aged 18-80 years, males or females; 2. Histologically or cytologically confirmed as ESCC; 3. Esophageal squamous cell carcinoma without anti-tumor treatment, and the clinical stage is T1b-2N+M0 or T3-4aN+/-M0 (AJCC/UICC TNM staging system 8th edition); 4. It can provide tumor tissue for the detection of PD-L1 expression level; 5. Follow-up surgery plan: radical esophageal squamous cell carcinoma surgery with esophagogastric reconstruction combined with at least complete 2 field lymph node dissection; 6. ECOG: 0\~1; 7. Expected survival time ≥ 12 weeks; 8. Body mass index (BMI) ≥ 18.5kg/m2 or pg-sga score A / B; 9. 1)White blood cell count (WBC) ≥3.0 × 109/L, absolute neutrophil count (ANC) ≥1.5 × 109/L, platelet (PLT) count ≥100×109/L, hemoglobin (HGB) ≥90 g/L, No blood transfusion or other hematopoietic factor treatment for the previous 14 days; 2)Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5×upper limit of normal (ULN); serum total bilirubin (TBIL) ≤1.5×ULN ; Albumin (ALB) ≥30g/L; 3)Serum creatinine (CRE)≤1.0×ULN, creatinine clearance (Ccr)≥60 mL/min (Cockcroft-Gault formula); 4)International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) ≤ 1.5 × ULN; 10. Important organ functions: a) Heart function: normal or grade I; b) Lung function: FEV1\>1.2L, FEV1% \>40%; c) Liver function: Child-Pugh grade 5-6 points; 11. For premenopausal women (postmenopausal women must have been postmenopausal for at least 12 months to be considered infertile), the serum pregnancy test result is negative. Male subjects (including male subjects' female spouses of childbearing age) and female subjects of childbearing age must contraception from the first study drug administration to 6 months after the last study drug administration; 12. Obtain the informed consent signed by the subject or his legal representative; 13. Can cooperate to complete research procedures and follow-up inspections。 Exclusion Criteria: 1. Cervical esophageal squamous cell carcinoma; 2. Combined with cervical, supraclavicular, abdominal, retroperitoneal and pelvic lymph node metastasis (except pericardial lymph node metastasis and left gastric lymph node metastasis); 3. Previously received anti-tumor therapy for the primary disease (including surgery, chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy, radiotherapy, radiofrequency ablation, etc.) and other research treatments, except for Chinese patent medicines or Chinese herbal medicines stopped for more than 7 days ; 4. Previously received anti-tumor therapy for the primary disease (including surgery, chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy, radiotherapy, radiofrequency ablation, etc.) and other research treatments, except for Chinese patent medicines or Chinese herbal medicines stopped for more than 7 days ; 5. Previously active, potentially relapsed or undiagnosed autoimmune diseases, skin diseases (vitiligo, psoriasis, alopecia) without systemic treatment, well controlled type I diabetes, hypothyroidism (only thyroid hormone replacement therapy), and other diseases that were not expected to relapse under external stimulation were included. 6. History of allogeneic stem cell transplantation or organ transplantation; 7. Complicated with interstitial pneumonia or interstitial lung disease, non infectious pneumonia; 8. History of gastrointestinal perforation and/or fistula, abdominal abscess, visceral fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive within 6 months before the first study drug administration bowel resection (including partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea; 9. Major operations (except puncture and biopsy) or major trauma were performed ≤ 28 days before the administration of the first study drug; 10. Have vaccinated or plan to vaccinate live vaccine within 28 days before the first study drug administration; 11. Use corticosteroids (\>10 mg/day prednisone or equivalent dose) or other immunosuppressive agents within 14 days before the first study drug administration. Inhalation, ophthalmic, intra-articular, intranasal or topical corticosteroids can be used prophylactically for short-term (≤7 days) use of corticosteroids (for example, to prevent allergy to contrast agents) or for the treatment of non-autoimmune conditions (for example, delayed hypersensitivity caused by contact with allergens) 12. Infectious diseases that affect activities of daily living or require systemic treatment (such as the use of hormones, antibiotics, antifungal drugs, antiviral drugs, and oxygen inhalation) within 14 days before the first study drug administration, including but not limited to the need Hospitalized infections, bacteremia, severe pneumonia, etc.; 13. Combined with the following diseases that have not been well controlled, such as: a) New York Heart Association (NYHA) ≥ Grade 2 heart failure, b) Severe/Unstable Angina, c) Myocardial infarction ≤ 6 months before study administration, d) Severe arrhythmia requiring medication or intervention, e) Uncontrollable hypertension, f) Occurrence/combined arterial and/or venous thromboembolism ≤2 months before the first study administration, g) ≤6 before the first study administration A cerebrovascular accident occurred within a month, h) diabetes that has not been effectively controlled, i) thyroid disease that has not been effectively controlled, j) urine protein ≥ 2+ and 24-hour urine protein quantification ≥ 1.0g; 14. Tuberculosis (TB) who has received anti-tuberculosis treatment within 1 year before receiving/receiving/first study administration; 15. Human immunodeficiency virus infection (HIV1/2 antibody positive); 16. Acute or chronic active hepatitis B and / or hepatitis C: positive for hepatitis B virus surface antigen (HBsAg) / positive for hepatitis B virus core antibody (HBcAb) and positive for hepatitis B virus DNA (HBV DNA \>2000 IU/ml or 103 copies /ml), if HBsAg/HB cAb positive, HBV DNA less than 2000 IU/ml or 103 copies of /ml can be entered, but entecavir or other anti HBV drugs should be taken simultaneously; hepatitis C virus (positive) antibody is positive and HBV copies; 17. Pregnant or lactating women; 18. Complicated with other malignant tumors ≤5 years before the first study drug administration, various cancers in situ, skin basal cell carcinoma or squamous cell carcinoma that have been cured in the past, local prostate cancer after radical resection, and catheters after radical resection except for carcinoma in situ; 19. Combined with other severe, acute, chronic or mental illness that may increase the risk of study medication or may interfere with the interpretation of the study results, the presence of alcoholism, drug abuse, or drug abuse, and other conditions that are not conducive to study drug administration, drug toxicity or adverse events (AE) Circumstances that lead to a decrease in the compliance of research behavior; 20. Other circumstances that the researcher considers inappropriate to participate in the study.

Treatments Being Tested

DRUG

A:non-pCR patients

After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), non-pCR patients adjuvant treatment(2-4 cycles Camrelizumab+Albumin Paclitaxel+Cisplatin and Camrelizumab maintenance treatment) Camrelizumab, 200 mg,Intravenous injection,q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication

DRUG

B:non-pCR patients

After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), non-pCR patients adjuvant treatment(Camrelizumab maintenance treatment) Camrelizumab, 200 mg,Intravenous injection,q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication

DRUG

A:pCR patients

After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), pCR patients adjuvant treatment(Camrelizumab maintenance treatment) Camrelizumab, 200 mg,Intravenous injection,q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication

DRUG

B:pCR patients

After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), pCR patients adjuvant treatment(Best Supportive Care) Camrelizumab, 200 mg,Intravenous injection,q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication

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.

The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05182944), the sponsor (The First Affiliated Hospital of Zhengzhou University), 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 NCT05182944 clinical trial studying?

The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05182944?

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 NCT05182944?

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 NCT05182944. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05182944. 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.