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A prospective, open, one arm clinical study of Camrelizumab combined with chemotherapy as neoadjuvant therapy for locally advanced resectable stage III esophageal squamous cell carcinoma

A prospective, open, one arm clinical study of Camrelizumab combined with chemotherapy as neoadjuvant therapy for locally advanced resectable stage III esophageal squamous cell carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046353
Enrollment
Unknown
Registered
2021-05-14
Start date
2021-05-14
Completion date
Unknown
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

experimental group:Camrelizumab + albumin paclitaxel + nedaplatin

Sponsors

Anhui Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18~75 years old, no gender limit; 2. Patients with resectable esophageal squamous cell carcinoma confirmed by histopathology or cytology (cT1-3N1-2M0 and cT4aN0-1M0 patients); 3. No previous treatment, including surgery, chemotherapy, radiotherapy, immunotherapy and targeted therapy; 4. ECOG PS score 0-1 points; 5. Estimated survival period >= 6 months; 6. The main organ functions are normal, and there are no patients with severe blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immunodeficiency. 7. Laboratory inspection meets the following requirements: (1) Hemoglobin (Hb) >=110 g/L; (2) White blood cell (WBC)>=3.5x10^9/L; Neutrophil count (NEUT)>=1.5x10^9/L; (3) Platelets (PLT) >=100x10^9/L (4) Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level <=2.5 times the upper limit of normal (ULN); renal function (serum creatinine sCr) level <=1.5 times the upper limit of normal (ULN); (5) Total bilirubin (TBIL) <= 1.5 times the upper limit of normal (ULN); (6) TSH normal range; if TSH is abnormal, total T3 or free T3, free T4 should be in the normal range; 8. Subjects voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up; 9. The investigator believes that the treatment can benefit.

Exclusion criteria

Exclusion criteria: 1. Those who have been confirmed to be allergic to the test drug and/or its excipients; 2. Subjects suffering from childhood asthma that have been completely relieved and do not require any intervention or vitiligo after adulthood can be included, and subjects who require medical intervention with bronchodilators cannot be included; 3. Have a history of organ transplantation; 4. Pregnant or lactating women; 5. According to the judgment of the investigator, patients who are not suitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
Pathological complete remission rate;

Countries

China

Contacts

Public ContactZhang Anqing

Anhui Cancer Hospital

1401517021@qq.com+86 13856512825

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026