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Clinical Trials/NCT07312578
NCT07312578
Enrolling By Invitation
Phase 2

A Prospective, Open Label, Randomized Controlled, Phase II Clinical Study of the Combination of Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Peking University1 site in 1 country48 target enrollmentStarted: November 1, 2025Last updated:
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InterventionsNimotuzumabcamrelizumabAlbumin paclitaxelCisplatin

Overview

Phase
Phase 2
Status
Enrolling By Invitation
Sponsor
Peking University
Enrollment
48
Locations
1
Primary Endpoint
Pathological complete response (pCR) rate
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

We plan to conduct a single-center,prospective, Open Label, Randomized Controlled, Phase II Clinical Study of the Combination of Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Detailed Description

This study is a prospective, randomized controlled, open label clinical trial aimed at evaluating the efficacy and safety of the combination of nimotuzumab,camrelizumab, and neoadjuvant chemotherapy in patients with locally advanced resectable esophageal squamous cell carcinoma. The enrolled patients will receive neoadjuvant therapy (camrelizumab ±nimotuzumab+Albumin Paclitaxel+Cisplatin) and esophageal cancer radical surgery (performed within 4 weeks after the last drug treatment). This study includes screening period, treatment period, efficacy follow-up period, and survival follow-up period.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Sign the informed consent form;
  • •Age range: 18-70 years old, both male and female are acceptable;
  • •Esophageal squamous cell carcinoma patients diagnosed by histology or cytology; 4.ECOG：0～1；
  • •Expected survival period ≥ 12 weeks;
  • •Have not received any treatment for primary esophageal tumors in the past, including drug therapy, surgical treatment, and radiation therapy, etc;
  • •Clinical staging: cT1-4a, N1-3, M0 (AJCC/UICC esophageal cancer staging (8th edition)), can be surgically resected;
  • •Important organ functions meet the following requirements:
  • •Absolute neutrophil count ≥ 1.5 × 109, platelet count ≥ 80 × 109, hemoglobin count ≥ 90g/L;
  • •Total bilirubin level ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN (for patients with liver metastases, AST and ALT levels ≤ 5 times ULN);
  • •Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60 ml/min (Cockcroft Gault formula);

Exclusion Criteria

  • •1\. Patients with any active autoimmune diseases or autoimmune diseases (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that has been completely relieved in childhood and does not require any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included);
  • •The patient is currently using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose\>10mg/day of prednisone or other therapeutic hormones), and has continued to use them within the 2 weeks prior to enrollment;
  • •Previously received treatment with EGFR monoclonal antibodies or EGFR tyrosine kinase inhibitors;
  • •Patients with any severe and/or uncontrolled illnesses, including:
  • •Patients with poor blood pressure control (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100 mmHg); Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including QT interval ≥ 480ms), and grade I cardiac dysfunction;
  • •Active or uncontrolled severe infections;
  • •Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 104 copies/ml or 2000IU/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method);
  • •Patients whose imaging shows that the tumor has invaded important blood vessels or whose researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal bleeding during subsequent studies;
  • •Pregnant or lactating women; Patients with other malignant tumors within 7.5 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ);
  • •Patients with a history of abuse of psychotropic drugs who cannot be quit or those with mental disorders;

Arms & Interventions

Nimotuzumab+Camrelizumab+Neoadjuvant chemotherapy（nCT）

Experimental

Experimental group:

  1. Nimotuzumab: 400mg, Intravenous（iv）, day1（D1）, quaque week（QW）, 6 cycles;
  2. Camrelizumab: 200mg, iv, D1, Q3W, 2 cycles;
  3. Albumin paclitaxel: 125mg/m2, iv, D1, D8, Q3W, 2 cycles;
  4. Cisplatin: 75mg/m2, iv, D1, Q3W, 2 cycles.

Intervention: Nimotuzumab (Drug)

Nimotuzumab+Camrelizumab+Neoadjuvant chemotherapy（nCT）

Experimental

Experimental group:

  1. Nimotuzumab: 400mg, Intravenous（iv）, day1（D1）, quaque week（QW）, 6 cycles;
  2. Camrelizumab: 200mg, iv, D1, Q3W, 2 cycles;
  3. Albumin paclitaxel: 125mg/m2, iv, D1, D8, Q3W, 2 cycles;
  4. Cisplatin: 75mg/m2, iv, D1, Q3W, 2 cycles.

Intervention: camrelizumab (Drug)

Nimotuzumab+Camrelizumab+Neoadjuvant chemotherapy（nCT）

Experimental

Experimental group:

  1. Nimotuzumab: 400mg, Intravenous（iv）, day1（D1）, quaque week（QW）, 6 cycles;
  2. Camrelizumab: 200mg, iv, D1, Q3W, 2 cycles;
  3. Albumin paclitaxel: 125mg/m2, iv, D1, D8, Q3W, 2 cycles;
  4. Cisplatin: 75mg/m2, iv, D1, Q3W, 2 cycles.

Intervention: Albumin paclitaxel (Drug)

Nimotuzumab+Camrelizumab+Neoadjuvant chemotherapy（nCT）

Experimental

Experimental group:

  1. Nimotuzumab: 400mg, Intravenous（iv）, day1（D1）, quaque week（QW）, 6 cycles;
  2. Camrelizumab: 200mg, iv, D1, Q3W, 2 cycles;
  3. Albumin paclitaxel: 125mg/m2, iv, D1, D8, Q3W, 2 cycles;
  4. Cisplatin: 75mg/m2, iv, D1, Q3W, 2 cycles.

Intervention: Cisplatin (Drug)

Camrelizumab+Neoadjuvant chemotherapy（nCT）

Active Comparator
  1. Camrelizumab: 200mg, iv, D1, Q3W, 2 cycles;
  2. Albumin paclitaxel: 125mg/m2, iv, D1, D8, Q3W, 2 cycles;
  3. Cisplatin: 75mg/m2, iv, D1, Q3W, 2 cycles.

Intervention: camrelizumab (Drug)

Camrelizumab+Neoadjuvant chemotherapy（nCT）

Active Comparator
  1. Camrelizumab: 200mg, iv, D1, Q3W, 2 cycles;
  2. Albumin paclitaxel: 125mg/m2, iv, D1, D8, Q3W, 2 cycles;
  3. Cisplatin: 75mg/m2, iv, D1, Q3W, 2 cycles.

Intervention: Albumin paclitaxel (Drug)

Camrelizumab+Neoadjuvant chemotherapy（nCT）

Active Comparator
  1. Camrelizumab: 200mg, iv, D1, Q3W, 2 cycles;
  2. Albumin paclitaxel: 125mg/m2, iv, D1, D8, Q3W, 2 cycles;
  3. Cisplatin: 75mg/m2, iv, D1, Q3W, 2 cycles.

Intervention: Cisplatin (Drug)

Outcomes

Primary Outcomes

Pathological complete response (pCR) rate

Time Frame: up to 2 years

Pathological complete response (pCR) rate

Secondary Outcomes

  • Event-free survival （EFS）(from enrollment until firstly confirmed and recorded disease progression or death，assessed up to 3 years)

Investigators

Sponsor
Peking University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shen Lin

Department of Digestive Oncology

Peking University

Study Sites (1)

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