A Clinical Study on the Efficacy and Safety of Paclitaxel Polymer Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma

April 5, 2024 updated by: Sun Jing

A Clinical Study on the Efficacy and Safety of Paclitaxel Polymer Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma：A Single Arm, Single Center, Prospective Clinical Trial (POINTS Trial)

The purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1/CTLA-4 bispecific antibody (cadonilimab) in combination with platinum-containing chemotherapy (paclitaxel polymer micelles combined with cisplatin). Includes pathologic complete remission rates (pCR rates) after 2-4 cycles of cadonilimab combination chemotherapy. The objective remission rate (ORR), major pathologic remission rate (MPR), R0 resection rate and 2-year overall survival (OS) and progression-free survival (OS) rates, and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with cadonilimab combined with chemotherapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years, ≤75 years, gender is not limited;
  2. Squamous esophageal cancer of thoracic segment confirmed by pathology;
  3. Locally advanced patients with no distant metastasis by imaging, resectable or potentially resectable after discussion among oncology, esophageal surgery, and imaging, and clinical stage cT2-4aN+ or cT3-4aN0, M0, stage II, III, or IVA (AJCC 8th edition cTNM staging);
  4. ECOG PS score of 0-1;
  5. No previous antitumor treatment such as radiotherapy, chemotherapy and immunotherapy;
  6. Expected survival > 6 months;
  7. Adequate baseline organ function: (i) WBC ≥3×10^9/L, ANC ≥1.5×10^9/L, PLT ≥100×10^9/L, Hb ≥9g/dL; (ii) Liver function: TBIL ≤2ULN, AST ≤2.5ULN, ALT ≤2.5ULN; (iii) Renal function: cCr>40 ml/min, Cr≤1.5 ULN; (iv) Cardiac function: no cardiac disease or coronary artery disease. Cardiac function: no heart disease or coronary heart disease, patients with cardiac function grade 1-2;
  8. Hypertensive patients applying antihypertensive drugs to control blood pressure within the normal range;
  9. Diabetic patients with fasting blood glucose controlled at ≤8mmol/L by hypoglycemic drug treatment;
  10. No other serious diseases (such as autoimmune diseases, immunodeficiency, organ transplantation, or other diseases that require continuous hormone therapy) that conflict with this protocol;
  11. No history of other malignant tumors;
  12. The patient agrees to participate in this clinical study and signs the Informed Consent Form.

Exclusion Criteria:

  1. Patients who have previously received anti-tumor therapy (including chemotherapy, radiotherapy, surgery or immunotherapy, etc.);
  2. Combination of other incurable malignant tumors (except cured non-malignant skin tumors, cervical cancer in situ, and prostate cancer);
  3. Patient has or anticipates a significant risk of esophageal perforation, fistula, and hemorrhage;
  4. Active autoimmune or immunodeficiency disease, use of immunosuppressants prior to enrollment, and use of immunosuppressant dosage ≥10 mg/day of oral prednisone for more than 2 weeks;
  5. Clinically significant cardiovascular disease including, but not limited to, severe acute myocardial infarction, unstable or severe angina pectoris, coronary artery bypass grafting surgery, congestive heart failure, ventricular arrhythmia requiring medical intervention, left ventricular ejection fraction <50%, or other anticipated inability to tolerate chemoradiotherapy in the 6 months prior to enrollment;
  6. Severe allergies;
  7. Pregnant or lactating women;
  8. Severe mental disorders;
  9. Presence of CTC grade ≥3 peripheral nerve disease;
  10. Abnormal coagulation function (PT > 16s, APTT > 53s, TT > 21s, Fib < 1.5g/L), bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
  11. Presence of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, severe impairment of lung function, or active tuberculosis within 1 year;
  12. Presence of active hepatitis B or C;
  13. Any other condition that the investigator evaluates to be ineligible for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: paclitaxel polymer micelles and cisplatin combined with Camrelizumab
Drug: paclitaxel polymer micelles and cisplatin combined with Cadonilimab
Paclitaxel polymer micelles:Cycle 1: 230mg/m2, IV ≥3 hours; Cycles 2-4: If the patient has a neutrophil nadir ≥1.0 x 109/L along with a platelet nadir ≥80 x 109/L after Cycle 1 dosing and has not experienced grade II-IV non-hematologic toxicity, then give 260mg/m2, IV ≥3 hours, d1, q3w; Cisplatin: 25mg/m2/d x d1-3, IV drip, q3w; Cadonilimab: 375mg, IV drip, d3, q3w;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response (pCR) rates
Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
evaluate pathological complete response rate of primary tumor and locally metastatic lymph nodes after 2-4 cycles of neoadjuvant therapy.
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major pathological response (MPR)
Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Objective Rate of Effectiveness (ORR)
Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
the proportion of patients who achieve PR or CR
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
R0 Removal Rate
Time Frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Rate of microscopically margin-negative resection
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
2-year overall survival rate
Time Frame: 2 years
2-year overall survival rate
2 years
2-year disease free survival rate
Time Frame: 2 years
2-year disease free survival rate
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Jing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2024

Primary Completion (Estimated)

April 20, 2025

Study Completion (Estimated)

June 20, 2025

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13914704178

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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