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This is a multi-center, single-arm, phase II clinical study designed to observe and evaluate the effectiveness and safety of adebrelimab combined with albumin paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma.
This study plans to include 65 patients who received 3 cycles of neoadjuvant therapy (Adebrelimab + albumin paclitaxel + nedaplatin) , and underwent surgery after the treatment was completed. The purpose of this study is to explore and evaluate the effectiveness and safety of adebrelimab combined with albumin paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immuno-chemotherapy for locally advanced ESCC | Experimental | Adebrelimab + albumin paclitaxel + nedaplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | adebrelimab, IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete remission rate | After neoadjuvant therapy and surgery, there were no residual surviving tumor cells in the tumor bed in the postoperative specimens (% RVT=0) | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | The tumor lesion was completely removed, and no residual cancer cells were found on the cutting edge under the microscope | up to 24 months |
| Main pathological remission | After neoadjuvant therapy and surgery, the proportion of tumor cells remaining alive in the tumor bed in the postoperative specimen is less than or equal to 10% (% RVT ≤ 10) |
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Inclusion Criteria:
Age: 18 to 75 years old, no limit to male or female;
Surgically resectable locally advanced esophageal squamous cell carcinoma confirmed by histology or cytology (clinical stage: stage IIa-IIIb);
Have measurable lesions and meet RECIST v1.1) standards;
Have not received any anti-tumor systemic treatment for esophageal cancer in the past;
ECOG PS: 0-1 points;
Expected survival ≥12 weeks;
The functions of vital organs meet the following requirements:
Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method during the study treatment period and within 3 months after the end of the study treatment period; female patients of childbearing age who have non-surgical sterilization must use a medically approved contraceptive method before study enrollment. The serum or urine HCG test must be negative within 72 hours; and must be non-lactating; for males, they should be surgically sterilized, or agree to use appropriate contraceptive methods during the trial and within 3 months after the last administration of the trial drug;
The patient voluntarily joined this study, signed the informed consent form (ICF), had good compliance, and cooperated with the follow-up.
Exclusion Criteria:
1) NYHA class II or above heart failure; 2) Unstable angina; 3) Myocardial infarction within 1 year; 4) Clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 10. Severe active infection requiring intravenous antibiotic treatment occurs within 4 weeks before using the study drug; 11. Those who are allergic to experimental drugs; 12. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up visits; 13. Those who the researcher believes are not suitable to participate in this trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianqun Ma, MD | Contact | +86-13359990466 | jianqunma@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianqun Ma, MD | Harbin Medical University Affiliated Cancer Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C053989 | nedaplatin |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| albumin paclitaxel | Drug | albumin paclitaxel, iv |
|
|
| Nedaplatin | Drug | Nedaplatin,IV |
|
|
| up to 24 months |
| objective response rate | The proportion of patients whose tumors have shrunk to a certain amount and remained in remission for a certain period of time, including complete response (CR) and partial response (PR). | up to 24 months |
| Disease-free survival | It was calculated from the time of first administration of study drug until disease progression or death. | up to 24 months |
| overall survival | The time is calculated from the first administration of the study drug until death due to any cause (patients who were lost to follow-up are the last follow-up time; patients who are still alive at the end of the study are the end of follow-up date). | up to 24 months |
| Number of participants with treatment related adverse events asassessed by CTCAE v5.0 | Proportion of patients with treatment-related adverse events recorded using CTCAE 5.0 criteria | up to 24 months |
| Changes in the patient's mood | Use PHQ-9 and GAD-7 to record the changes in patients' emotions during treatment | up to 24 months |
| The patient's nutritional status | Use PNI, CNI and mCONUT scoring standards to record changes in the patient's nutritional status during treatment | up to 24 months |
| The pain level of patients | NRS and VAS pain rating scales were used to assess changes in patients' pain levels during treatment. | up to 24 months |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |