Overview

Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Resectable Esophageal Squamous Cell Carcinoma

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
Summary
This is a study to evaluate the efficacy and safety of preoperative treatment with durvalumab combined with neoajuvant therapy (carboplatin, paclitaxel with/without radiation) in locally advanced resectable oesophageal squamous carcinoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking Union Medical College Hospital
Treatments:
Carboplatin
Durvalumab
Paclitaxel
Criteria
Inclusion Criteria:

- Histologically proven squamous cell carcinoma of the esophagus.

- Surgical resectable (T3 or T4b, N0 or N+, M0), as determined by Endoscopic Ultra Sound
(EUS),PET/CT, Esophageal MRI and enhanced CT scan of neck, thorax and abdomen.

- Tumor length longitudinal ≤ 10 cm; if larger than 10 cm, inclusion should be discussed
with the principal investigator.

- 18≤Age≤75.

- Tumor does not involve gastro-esophageal junction.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Adequate hematological, renal and hepatic functions defined as:

neutrophiles ≥ 1.5 x 109/L platelets ≥ 100 x 109/L alanine transaminase≤2 x upper normal
limit hemoglobin ≥ 5.6 mmol total bilirubin ≤ 1.5 x upper normal limit creatinine clearance
(Cockroft) ≥60 ml/min

- Written, voluntary informed consent.

Exclusion Criteria:

- Past or current history of malignancy other than entry diagnosis interfering with
prognosis of esophageal cancer.

- T1, T2 tumors or in situ carcinoma.

- metastatic oesophageal cancer.

- Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.

- Previous chemotherapy, radiotherapy, and/or treatment with checkpoint inhibitors.

- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) precluding major surgery.

- Pulmonary fibrosis and/or severely impaired lung function precluding major surgery.

- Pre-existing motor or sensory neurotoxicity greater than WHO grade 1.

- Has an active autoimmune disease that has required systemic treatment in past 2 years
(i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
drugs).

- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (>10
mg/day prednisone or equivalent) or any other form of immunosuppressive therapy within
7 days prior to the first dose of trial treatment.

- Dementia or altered mental status that would prohibit the understanding and giving of
informed consent

- Serious underlying medical condition which would impair the ability of the patient to
receive the planned treatment, including prior allergic reactions to drugs containing
Cremophor, such as teniposide or cyclosporine.

- Has an active infection requiring systemic therapy which has not resolved 3 days
(simple infection such as cystitis) to 7 days (severe infection such as
pyelonephritis) prior to the first dose of trial treatment.

- Has a diagnosis of acute or chronic hepatitis B, hepatitis C, known immunodeficiency
or human immunodeficiency virus (HIV)

- Patients with prior allogeneic stem cell or solid organ transplantation.