- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04063683
Paclitaxel and DDP Combined With Anlotinib in the First-line Treatment for Patients With Advanced Esophageal Squamous Cell Carcinoma(ESCC).
August 23, 2021 updated by: Henan Cancer Hospital
Paclitaxel and DDP Combined With Anlotinib in the First-line Treatment for Patients With Advanced Esophageal Squamous Cell Carcinoma: a Single Arm, Multicentre Trial.
To evaluate the efficacy and safety of paclitaxel and DDP combined with Anlotinib in the treatment of advanced esophageal squamous cell carcinoma.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
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 Locations
-
-
Henan
-
Anyang, Henan, China, 455000
- Anyang Cancer Hospital
-
Luoyan, Henan, China
- First Affiliated Hospital of Henan University of Science and Technolog
-
Zhengzhou, Henan, China, 450000
- Henan Cancer Hospital
-
-
Shandong
-
Jinan, Shandong, China
- Shandong Cancer Hospital
-
Jinan, Shandong, China
- Qilu hospital
-
Linyi, Shandong, China
- Linyi Central Hospital
-
-
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:
- histopathology confirmed unresectable, locally recurrent or metastatic advanced esophageal squamous cell carcinoma (excluding mixed type adenosquamous carcinoma );
- Those who have not received systemic treatment before, or who relapsed after (new) adjuvant therapy/radical surgery more than 6 months ; Note: Including advanced or recurrent Patients who ever received only radiotherapy on non-target lesions. The duration from the end of palliative treatment for local lesions (non-target lesions) to enrollment should > 2 weeks;
- According to RECIST 1.1, at least one measurable lesion; the measurable lesions should not have received local treatment such as radiotherapy (for the lesions in the area where received local radiotherapy, it can also be regarded as a target lesion if confirmed to progress according to the recist1.1);
- Age from 18-75 years old;
- ECOG PS score: 0-1; expected survival time more than 3 months;
- Main organs function is normal;
- Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device,contraceptive and condom) throughout treatment and for at least 3 months after study is stopped;the result of serum or urine pregnancy test should be negative before enrollment;Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 2 months after study is stopped.
- Patients should participate in the study voluntarily and sign informed consent
Exclusion Criteria:
- Patients tends to have complete obstruction or patients requiring interventional treatment for obstruction;
- ulcerated esophageal squamous cell carcinoma patients;
- after esophageal or endotracheal stent implantation;
- Patients with a high risk of bleeding or perforation due to the apparent invasion of adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed fistulas;
- patients with ESCC who have not undergone surgical resection but have not reduced esophageal lesions after radiotherapy;
- allergic to paclitaxel and cisplatin preparations or excipients;
- Adjuvant chemotherapy patients who have used paclitaxel or cisplatin, and relapse or metastasize within one year;
- A variety of factors affecting oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
- The of liver metastases accounts for more than 50% of the total liver volume;
- patients with any severe and / or uncontrolled disease, including:Unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmhg or diastolic blood pressure ≥100) Mmhg) patients; patients with grade ≥ myocardial ischemia or myocardial infarction, arrhythmia (including qt interval ≥ 480ms); according to nyha criteria, iii-iv cardiac dysfunction, or cardiac ultrasonography prompted left ventricular ejection fraction (lvef) <50% of patients;live Severe infection that is sexual or uncontrolled;Liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis;poor diabetes control (fasting blood glucose (fbg)>10mmol/l);Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0 g;
- long-term unhealed wounds or fractures;
- Patients with active hemorrhage within 2 months of primary lesions; pulmonary hemorrhage with NCI CTC AE grade >1, 4 weeks before of enrollment; other sites of bleeding NCI CTC AE grade >2, 4 weeks before of enrollment; patients with bleeding tendency (such as active gastrointestinal ulcers) or patients undergoing thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues;
- Have undergone major surgery (craniotomy, thoracotomy or open surgery) within 4 weeks prior to the first dose study or Major surgery is required during the study period.
- A history of gastrointestinal perforation and/or fistula occurred within 6 months prior to treatment; or an overactive/venous thrombosis event such as a cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and lung Embolism.
- Symptomatic central nervous system metastasis and/or cancerous meningitis are known to exist;
- Clinically significant ascites, including any ascites that can be found on a physical examination, ascites that has been treated or currently in need of treatment, and only those with a small amount of ascites but no symptoms can be selected;
- A moderate amount of fluid in both sides of the chest, or a large amount of fluid in one side of the chest, or has caused respiratory dysfunction Patient to be drained;
- known to have active tuberculosis;
- suffering from interstitial lung disease requiring steroid therapy;
- Uncontrolled metabolic disorders or other non-malignant tumors or systemic diseases or cancer secondary reactions that can lead to higher medical risks and/or survival Evaluation of uncertainty;
- Significantly malnourished patients;
- those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder;
- A history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
- History of other primary malignancies, but the following : 1) complete remission of malignant tumors for at least 2 years prior to enrollment and no additional treatment during the study; 2) non-melanoma skin cancer or malignant freckle-like sputum with adequate treatment and no evidence of disease recurrence; 3) adequately treated and In situ carcinoma without evidence of disease recurrence;
- Female patients who are pregnant or breastfeeding
- According to the investigator's judgment, there are serious concomitant diseases that endanger the safety of the patient or affect the patient's completion of the study.
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Anlotinib with chemotherapy
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progress free survival (PFS)
Time Frame: From first treatment,each 42 or 63 days until PD or death(up to 24 months)
|
From first treatment,each 42 or 63 days until PD or death(up to 24 months)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective Response Rate (ORR)
Time Frame: each 42 or 63 days until intolerant the toxicity or PD (up to 24 months) ]
|
each 42 or 63 days until intolerant the toxicity or PD (up to 24 months) ]
|
Disease Control Rate (DCR)
Time Frame: each 42 or 63 days until intolerant the toxicity or PD (up to 24 months) ]
|
each 42 or 63 days until intolerant the toxicity or PD (up to 24 months) ]
|
Duration of Response(DOR)
Time Frame: each 42 or 63 days until intolerant the toxicity or PD (up to 24 months)
|
each 42 or 63 days until intolerant the toxicity or PD (up to 24 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: LUO SUXIA, Henan 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)
October 7, 2019
Primary Completion (ANTICIPATED)
March 1, 2022
Study Completion (ANTICIPATED)
June 1, 2022
Study Registration Dates
First Submitted
August 19, 2019
First Submitted That Met QC Criteria
August 19, 2019
First Posted (ACTUAL)
August 21, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 24, 2021
Last Update Submitted That Met QC Criteria
August 23, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
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
- Esophageal Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
Other Study ID Numbers
- 2019315
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
Clinical Trials on Esophageal Squamous Cell Carcinoma
-
Cancer Institute and Hospital, Chinese Academy...Akeso Pharmaceuticals, Inc.Not yet recruitingMetastatic Esophageal Squamous Cell Carcinoma | Unresectable Esophageal Squamous Cell Carcinoma | Locally Advanced Esophageal Squamous Cell Carcinoma
-
National Cancer Institute (NCI)TerminatedEsophageal Cancer | Esophageal Neoplasms | Esophageal Adenocarcinoma | Squamous Cell Carcinoma | Esophageal Squamous Cell CancerUnited States
-
Peking UniversityUnknownAdvanced Esophageal Squamous CarcinomaChina
-
Fujian Medical University Union HospitalNot yet recruitingEsophageal Squamous Cell Carcinoma Thoracic Stage II | Esophageal Squamous Cell Carcinoma Thoracic Stage III | Esophageal Squamous Cell Carcinoma Thoracic Stage IVChina
-
The First Affiliated Hospital of Henan University...Luoyang Central Hospital; Nanyang Central Hospital; Sanmenxia Central Hospital; Military 150 Hospital and other collaboratorsActive, not recruitingStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell CarcinomaChina
-
The First Affiliated Hospital of Henan University...UnknownStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell CarcinomaChina
-
The First Affiliated Hospital of Henan University...UnknownStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell CarcinomaChina
-
Jiangsu Cancer Institute & HospitalRecruitingLocally Advanced Esophageal CarcinomaChina
-
Shanghai Zhongshan HospitalZhejiang Cancer Hospital; Sun Yat-sen University; Cancer Institute and Hospital... and other collaboratorsRecruitingEsophageal Squamous Cell Carcinoma Stage II | Esophageal Squamous Cell Carcinoma Stage IIIChina
-
The First Affiliated Hospital of Henan University...UnknownStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell Carcinoma | Stage I Esophageal Adenocarcinoma | Stage II Esophageal Adenocarcinoma | Stage III Esophageal Adenocarcinoma | Stage I Esophageal Squamous Cell CarcinomaChina
Clinical Trials on Anlotinib Hydrochloride, Paclitaxel, cisplatin
-
Nanfang Hospital, Southern Medical UniversityNot yet recruitingNeoadjuvant Therapy | Esophageal Carcinoma
-
Nanfang Hospital of Southern Medical UniversityRecruiting
-
Peking Union Medical College HospitalRecruitingPheochromocytoma | ParagangliomaChina
-
Peking Union Medical College HospitalRecruitingParaganglioma, Extra-Adrenal | Malignant Adrenal Gland Pheochromocytoma | Malignant Paraganglioma | Pheochromocytoma, Metastatic | Paraganglioma, MalignantChina
-
First People's Hospital of HangzhouChia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingRecurrent High-grade GliomaChina
-
Peng YuanCompletedBreast Neoplasm | Antineoplastic Agents | AnlotinibChina
-
Sun Yat-sen UniversityChia Tai Tianqing Pharmaceutical Group Co., Ltd.Recruiting
-
First Hospital of Shijiazhuang CityUnknownCarcinoma | Small Cell Lung Cancer | Lung NeoplasmChina
-
First Hospital of Shijiazhuang CityUnknownCarcinoma | Non-small Cell Lung Cancer | Lung NeoplasmChina
-
Third Military Medical UniversityRecruitingSmall Cell Lung Cancer | Lung Cancer | SCLC, Extensive StageChina