Clinical trial · Interventional
Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Resectable Esophageal Squamous Cell Carcinoma
A Prospective, Randomized Controlled Study to Evaluate the Efficacy and Safety of Durvalumab Combined With Neoadjuvant Therapy in Patients With Local Advanced Esophageal Squamous Cell Carcinoma
NCT04568200CI-TRIAL-00073144completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Durvalumab | Drug | Durvalumab | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Radiotherapy 23 x 1.8 Gy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- durvalumab and neoadjuvant therapy
- description
- durvalumab 1500mg i.v. day 1-22-43-64 Carboplatin AUC = 4-5 i.v day 1-22-43-64 Paclitaxel 75 mg/m2 i.v day 1-22-43-64 with/without Radiotherapy 23 x 1.8 Gy
- interventionNames
- Drug: Durvalumab
- Drug: Carboplatin
- Drug: Paclitaxel
- Radiation: Radiotherapy 23 x 1.8 Gy
- type
- PLACEBO_COMPARATOR
- label
- normal saline and neoadjuvant therapy
- description
- normal saline 500ml i.v. day 1-22-43-64 Carboplatin AUC = 4-5 i.v day 1-22-43-64 Paclitaxel 75 mg/m2 i.v day 1-22-43-64 with/without Radiotherapy 23 x 1.8 Gy
- interventionNames
- Drug: Carboplatin
- Drug: Paclitaxel
- Radiation: Radiotherapy 23 x 1.8 Gy
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.