Envafolimab Combined With Chemotherapy in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma

NCT05552651 | Unknown Phase 2

• 1 other identifier: 202208-20
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective is to investigate the efficacy and safety of envafolimab combined with chemotherapy for preoperative neoadjuvant therapy in patients with resectable esophageal squamous cell carcinoma

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Rate of pCR

  Rate of pathological complete remission

  From Baseline to primary completion date, about 6 months

Secondary Outcomes (1)

• Rate of MPR

  From Baseline to primary completion date, about 6 months

Other Outcomes (1)

• Rate of SAE

  From Baseline to primary completion date, about 18 months

Study Arms (1)

Envafolimab plus chemotherapy

EXPERIMENTAL

Drug: Envafolimab; Drug: Albumin-Bound Paclitaxel; Drug: Carboplatin

Interventions

Envafolimab DRUG

300mg,sc,d1,Q3W;

Envafolimab plus chemotherapy

Albumin-Bound Paclitaxel DRUG

130mg/m2,iv,D1,D8,Q3W

Envafolimab plus chemotherapy

Carboplatin DRUG

AUC=5, iv,D1,Q3W

Envafolimab plus chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily joined the study, signed the informed consent form, and had good compliance;
• years；
• ECOG 0-1；
• life expectancy of at least 3 months；
• For patients diagnosed with thoracic esophageal squamous cell carcinoma by histopathological examination of the primary tumor, the stage of esophageal cancer was clearly diagnosed as cT1b-cT2 N+ or cT3-cT4a anyN stage by CT or MRI or color Doppler ultrasound or PET-CT or ultrasonography before surgery , and evaluated by the investigator as suitable for patients treated with this study protocol.
• Not received any anti-tumor therapy in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc. However, exploratory thoracotomy, mediastinoscopy, excisional biopsy or similar surgical procedures for definite diagnosis, staging and surgical treatment of esophageal cancer can be accepted.
• Satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥80×109/L, Serum creatinine（CR）≤1.5 upper normal limitation (UNL)，total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; left ventricular ejection fraction (LVEF) ≥ 50%; thyroid stimulating hormone (TSH) within the normal range Within: if the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
• The doctor's clinical judgment has sufficient organ function;
• Subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects ；

You may not qualify if:

• Suffered from other malignant tumors within 5 years before the start of treatment in this study;
• Patients with tumor invading the cervical esophagus or high upper thoracic segment requiring a laryngectomy;
• Patients with a high risk of bleeding or perforation due to the obvious invasion of the tumor into the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have already formed a fistula;
• Subjects with any severe and/or uncontrolled disease;
• Poor blood pressure control (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg);
• Subjects with any severe and/or uncontrolled disease ；
• Have clinical symptoms or diseases of the heart that are not well controlled；
• Patients with past and current objective evidence of history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired lung function；
• Acute or chronic active hepatitis B (hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive patients need to be tested for hepatitis B virus (HBV) DNA, such as HBV DNA copy number ≤2×103 copies/ml or ≤200 IU/ml or below the lower limit of detection, can be enrolled. HBsAg (+) subjects should receive anti-HBV therapy throughout the study drug treatment period to avoid viral activation. For anti-HBV Subjects with HBc(+), HBsAg(-), anti-HBs(-) and HBV viral load(-) do not need to receive preventive anti-HBV treatment, but need to be closely monitored for virus reactivation;
• A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• Poor control of diabetes (fasting blood glucose \[FBG\]\> 10mmol/L);
• Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;
• Those who have received major surgical treatment, incision biopsy or obvious traumatic injury within 28 days before the start of study treatment; or have long-term unhealed wounds or fractures;
• Serious arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, occurred within 6 months before the start of study treatment;
• Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders;

Sponsors & Collaborators

• Tao Jiang: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

envafolimab; Albumin-Bound Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes

Central Study Contacts

Tao Jiang

CONTACT

13991230762; 2585408668@qq.com

shi cao li

CONTACT

029-84717761; tangduec@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department director

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 23, 2022
• Study Start: September 20, 2022
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share