Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04568200
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Durvalumab Drug: Carboplatin Drug: Paclitaxel Radiation: Radiotherapy 23 x 1.8 Gy Phase 2

Detailed Description:

The primary objective of the study is to assess the tumor response (by irRECIST) and pathological response of preoperative treatment with durvalumab combined with neoadjuvant therapy (carboplatin, paclitaxel with/without radiation).

Secondary objectives are:

To assess completion of treatment with durvalumab combined with chemotherapy with/without radiation treatment.

To assess toxicities of durvalumab in combination with chemoradiation. [Time Frame: up to 1 year] To assess completion of chemotherapy with/without radiation treatment. To assess withdrawal rate from surgery. To assess delay rate from surgery. To assess R0 resection rate. To assess post-operative complications. Progression Free Survival. [ Time Frame: up to 24 months ] Overall Survival. [ Time Frame: up to 24 months ]

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 19, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: durvalumab and neoadjuvant therapy
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
 Drug: Durvalumab
Durvalumab 1500mg i.v. day 1-22-43-64

Drug: Carboplatin
Chemotherapy
Other Name: Chemotherapy

Drug: Paclitaxel
Chemotherapy
Other Name: Chemotherapy

Radiation: Radiotherapy 23 x 1.8 Gy
Radiotherapy 23 x 1.8 Gy
Other Name: Radiotherapy
Placebo Comparator: normal saline and neoadjuvant therapy
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
 Drug: Carboplatin
Chemotherapy
Other Name: Chemotherapy

Drug: Paclitaxel
Chemotherapy
Other Name: Chemotherapy

Radiation: Radiotherapy 23 x 1.8 Gy
Radiotherapy 23 x 1.8 Gy
Other Name: Radiotherapy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. tumor response [ Time Frame: up to 12 months ]
    assess the tumor response (by irRECIST) of preoperative treatment with durvalumab combined with neoadjuvant therapy

  2. pathological response [ Time Frame: up to 12 months ]
    assess the pathological response (by CAP classification) of preoperative treatment with durvalumab combined with neoadjuvant therapy


Secondary Outcome Measures :
  1. Percentage completion of treatment with durvalumab combined with chemotherapy with/without radiation treatment [ Time Frame: up to 3 months ]
    Percentage completion of treatment with durvalumab combined with chemotherapy with/without radiation treatment

  2. Incidence and severity of toxicity [ Time Frame: up to 12 months ]
    Incidence and severity of toxicity defined to CTCAE v4.03 and Radiation Oncology Group (RTOG) criteria

  3. Percentage completion of chemotherapy with/without radiation treatment [ Time Frame: up to 3 months ]
    Percentage completion of chemotherapy with/without radiation treatment

  4. Percentage withdrawal rate from surgery due to durvalumab related complications [ Time Frame: up to 3 months ]
    Percentage withdrawal rate from surgery due to durvalumab related complications

  5. Percentage delay of surgery due to durvalumab related complications [ Time Frame: up to 3 months ]
    Percentage delay of surgery due to durvalumab related complications

  6. R0 resection rate [ Time Frame: up to 3 months ]
    R0 resection rate

  7. Incidence and severity of post-operative complications to the Dindo classification [ Time Frame: up to 3 months ]
    Incidence and severity of post-operative complications to the Dindo classification

  8. Progression free survival [ Time Frame: up to 24 months ]
    Progression free survival

  9. Overall survival [ Time Frame: up to 24 months ]
    Overall survival


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568200


Contacts
Layout table for location contacts
Contact: Jia He, MD +86-13810096213 hejia@126.com
Contact: Luo Zhao, MD +86-18519667758 zhaoluo@pumch.cn

Locations
Layout table for location information
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Jia He, MD    +86-13810096213    hejia@126.com   
Contact: Luo Zhao, MD    +86-18519667758    Zhaoluo@pumch.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Layout table for investigator information
Study Chair: Jia He, MD Peking Union Medical College Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04568200    
Other Study ID Numbers: 69152630
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Esophageal 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
Paclitaxel
Carboplatin
Durvalumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological