- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05007145
PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Subjects With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma (REVO)
December 5, 2021 updated by: Fujian Cancer Hospital
A Randomized, Open-label, Phase II Study of PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy in Subjects With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
The purpose of this study is to explore the efficacy and safety of compare the efficacy and safety of PD-1 inhibitor and chemotherapy(treatment group) with chemoradiotherapy(control group) in neoadjuvant treatment of resectable thoracic esophageal squamous cell carcinoma.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
This is a randomized, open-label, phase II study of PD-1 inhibitor combined With neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy in subjects With resectable locally advanced thoracic esophageal squamous cell carcinoma.
The patients will be divided into two groups(1:1).
In the treatment group, PD-1 inhibitor ,albumin-bound paclitaxel and cisplatin will be given every 3 weeks for 2-4 cycles as neoadjuvant therapy.
In the control gourp, albumin-bound paclitaxel and cisplatin will be given every 3 weeks for 2 cycles as neoadjuvant therapy.
Study Type
Interventional
Enrollment (Anticipated)
92
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shuoyan Liu
- Phone Number: +86 13805088816
- Email: shuoyanliu2010@163.com
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China
- Recruiting
- Fujian Cancer Hospital
-
Contact:
- Shuoyan Liu
-
Longyan, Fujian, China
- Not yet recruiting
- The Second Hospital of Longyan
-
Contact:
- Rongxing Liu
-
Putian, Fujian, China
- Not yet recruiting
- The First Hospital of Putian City
-
Contact:
- Jiansheng Lin
-
Quanzhou, Fujian, China
- Not yet recruiting
- Fujian Medical University 2nd Affiliated Hospital
-
Contact:
- Zhijun Huang
-
Quanzhou, Fujian, China
- Not yet recruiting
- Quanzhou First Hospital
-
Contact:
- Rongqi He
-
Xiamen, Fujian, China
- Not yet recruiting
- The First Affiliated Hospital of Xiamen University
-
Contact:
- Xiuyi Liu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Volunteered to participate in the study, signed the informed consent form;
- Histologically or cytological confirmed esophageal squamous cell carcinoma;
- Patients with resectable disease of primary tumor in thoracic esophagus (cT1b-4aN1-3M0, cT3-4aN0M0) evaluated by CT/MRI/EUS;
- Expected R0 resection;
- Aged 18-75 years, male or female;
- ECOG PS 0-1;
- Without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment for esophageal cancer;
- Surgery is planned after neoadjuvant treatment;
- Without any contraindication of operation;
- Adequate organ function as follows: 1) Routine blood test: Leukocytes >=3.0x10^9/L; Absolute neutrophil count >=1.0x10^9/L; Platelet >=80x10^9/L; Hemoglobin >=90 g/L; 2) Blood biochemical test: Total bilirubin <=1.5 ULN; ALT <=2.5 ULN; AST <=2.5 ULN; Serum creatinine <=1.5 ULN or creatinine clearance rate >=50 mL/min (Cocheroft-Gault); 3) Coagulation function test: INR <=1.5 ULN; APTT <=1.5 ULN;
- For females of child bearing potential, a negative serum/urine pregnancy test result within 72h before study treatment. For female and male participants of reproductive potential must be willing to use adequate contraception for the course of the study until 3 months after the last dose of any of the drugs in the study;
- Had good compliance and cooperated with the follow-up.
Exclusion Criteria:
- The tumor invades the adjacent organs of the esophageal lesion (aorta or trachea);
- Patients with supraclavicular lymph node metastasis;
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- Poor nutritional status, BMI < 18.5 Kg/m2; If corrected after nutritional support before randomization, enrollment can be further considered after evaluation by the principal investigator;
- Has a history of allergy to monoclonal antibody, any component of PD-1 Inhibitor, paclitaxel, cisplatin or other platinum drugs;
- Has received or is receiving any of the following treatments: A)any anti-tumor radiation, chemotherapy or other treatment drugs; B) Immunosuppressive drugs or whole-body hormone drugs are being used for immunosuppressive purposes within 2 weeks prior to the first use of the study drug (dose > 10mg/ day prednisone or equivalent dose);Inhalation or topical use of steroids and 10 mg/ day prednisone or equivalent dose of adrenocortical hormone replacement is permitted in the absence of active autoimmune disease; C) Received attenuated vaccine within 4 weeks before the first use of the study drug; D) Major surgery or severe trauma within 4 weeks prior to the first use of the study drug;
- History of any active autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypohysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy);Patients with psoriasis or childhood asthma/allergy who have been in complete remission and do not need any intervention as adults may be considered for inclusion, but patients requiring medical intervention with bronchodilators may not be included;
- History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation;
- Present of poorly controlled cardiac symptoms or disease, including but not limited to: (1) heart failure with NYHA class II or above (2) unstable angina, (3)myocardial infarction occurred within 1 year (4) clinical significance supraventricular or ventricular arrhythmias without clinical intervention or poorly controlled after clinical intervention;
- Severe infection (CTCAE > 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, infection complications requiring hospitalization, etc.;Baseline chest imaging indicated active pulmonary inflammation, infection signs and symptoms within 14 days prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except prophylactic antibiotic usage;
- Patients who are found to have active pulmonary tuberculosis infection through medical history or CT, or have active pulmonary tuberculosis infection history within 1 year before enrollment, or have active pulmonary tuberculosis infection history more than 1 year before but without regular treatment;
- Have hereditary bleeding tendency or coagulation dysfunction. There were clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood++ and above at baseline;
- Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10^4 copies/mL), hepatitis C (HCV antibody positive, and HCV RNA higher than the detection limit of analytical method);
- Other malignancies diagnosed within 5 years prior to the first use of the study drug, except those with a low risk of metastasis or death (5-year survival rate > 90%), such as adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix;
- Pregnant or lactating women;
- In the investigator's judgment, there were other factors that might have contributed to the forced termination of the study, such as the need for combined treatment with other serious medical conditions (including mental illness), alcohol and drug abuse, family or social factors that might have affected the safety or compliance of the subjects.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PD-1 Inhibitor+albumin-bound paclitaxel+cisplatin
Participants receive PD-1 Inhibitor 200mg on Day 1 every 3 weeks (Q3W), albumin-bound paclitaxel 125 mg/m^2 on Day 1, 8 Q3W, and cisplatin 75 mg/m^2 on Day 1 Q3W, a total of 2-4 cycles,followed by surgery.
|
PD-1 Inhibitor 200mg D1 Q3W
125 mg/m^2 D1/D8 Q3W
75 mg/m^2 D1 Q3W
|
Active Comparator: Albumin-bound paclitaxel+cisplatin+radiotherapy
Participants receive albumin-bound paclitaxel 125 mg/m^2 on Day 1, 8 Q3W, and cisplatin 75 mg/m^2 on Day 1 Q3W, a total of 2 cycles combined with radiotherapy(40Gy/2Gy),followed by surgery.
|
125 mg/m^2 D1/D8 Q3W
75 mg/m^2 D1 Q3W
40Gy/2.0Gy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pathologic complete response (pCR) rate
Time Frame: Within 14 working days after surgery
|
Within 14 working days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
R0 resection rate
Time Frame: Within 14 working days after surgery
|
Within 14 working days after surgery
|
|
Overall Survival (OS)
Time Frame: Up to 8 years
|
OS is defined as the time from randomization until death from any cause.
|
Up to 8 years
|
Disease Free Survival (DFS)
Time Frame: Up to 8 years
|
The time from the first day of the date of surgery to local or distant recurrence, or death caused by any cause, whichever occurs first;
|
Up to 8 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Shuoyan Liu, Fujian Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2021
Primary Completion (Anticipated)
August 31, 2023
Study Completion (Anticipated)
August 31, 2023
Study Registration Dates
First Submitted
August 10, 2021
First Submitted That Met QC Criteria
August 12, 2021
First Posted (Actual)
August 16, 2021
Study Record Updates
Last Update Posted (Actual)
December 21, 2021
Last Update Submitted That Met QC Criteria
December 5, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Neoplasms
- Esophageal Squamous Cell Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
- Albumin-Bound Paclitaxel
- Immune Checkpoint Inhibitors
Other Study ID Numbers
- OBU-FJ-EC-II-007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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