- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04797507
SHR-1210 in Combination With Anlotinib in Patients With Advanced or Metastatic Esophageal Squamous Cell Cancer
March 11, 2021 updated by: Peking Union Medical College Hospital
SHR-1210, a Novel Anti-PD-1 Antibody, in Combination With Anlotinib As Second-line or Above Treatment in Patients With Advanced or Metastatic Esophageal Squamous Cell Cancer: a Phase II Study
This study was designed to explore the clinical efficacy of SHR-1210 in combined with Anlotinib in the treatment of second- or above- line advanced or metastatic esophageal squamous cell cancer patients, in order to find a better therapy strategy for esophageal squamous cell cancer patients.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
This is a prospective, phase II, single-arm clinical trial.
Advanced or metastatic esophageal squamous cell cancer(ESCC) patients progressed after 1st systematic treatment are treated with SHR-1210 and Anlotinib.
SHR-1210 was given intravenously(200mg d1 Q2w), combined with Anlotinib orally, 12 mg d1-14 Q3w.
The hypothesis: The objective response rate in SHR-1210 combined with Anlotinib can reach 40% as second-line or above treatment of advanced or metastatic ESCC patients.
The primary endpoint is objective response rate (ORR) and the secondary endpoint is disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and safety of this regimen.
Study Type
Interventional
Enrollment (Anticipated)
33
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: Junjie Gu, Doctor
- Phone Number: 86-10-69158773
- Email: gujunjie_ella@126.com
Study Contact Backup
- Name: Chunmei Bai, Doctor
- Phone Number: 86-10-69158773
- Email: baichunmei1964@163.com
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:
- Age:18 years to 75 years, male or female.
- Histologically or cytologically confirmed squamous cell carcinoma of the esophagus, locally advanced, unresectable, recurrent or metastatic disease.
- Progressed after first-line chemotherapy.
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
- Newly acquired or archived tumor tissue samples can be obtained.
- Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1
- Life expectancy >12 weeks.
- Adequate organ function.
- For females of child bearing potential, a negative urine or serum pregnancy test result within 1 week before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study until 4 months after the last dose of any of the drugs in the study.
- Willing and able to follow the study protocol and follow-up procedures for treatment and follow-up.
- Willing and able to provide written informed consent.
Exclusion Criteria:
Patients should not be selected for this clinical study if they have any of the following conditions:
- Abnormal coagulation function , with bleeding tendency or receiving thrombolytic or anticoagulant therapy. Note: Low-dose heparin (60,000-12,000 U/day for adults) or low-dose aspirin (≤100mg/day) are permitted for prophylactic purposes if INR≤1.5.
- The arterial/venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, pulmonary embolism, etc, occurred within 6 months before administration.
- Clinically significant hemoptysis occurred within 3 months before medication (hemoptysis > 50ml per day); Or clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occult blood ++ or above, or vasculitis, etc.
- Subjects with any active, known or suspected autoimmune disease or history of autoimmune disease.
- Received systemic steroid therapy within 3 days of the first dose of study medication.
- Received a live vaccine within 4 weeks of the first dose of study medication.
- Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.
- Imaging (CT or MRI) showed that the distance of the tumor lesion from great vessels was less than 5 mm, or invasion of local great vessels, or central tumor with high blood risk; Or there is obvious lung cavity or necrotizing tumor. Uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease.
- Pregnant or lactating female.
- Participate in other clinical trials currently or within 4 weeks prior to enrollment.
- Receiving other anti-cancer drugs (including anti-cancer traditional chinese medicine).
- Familial, sociological or geographical conditions that, in the clinical judgment of the Principal Investigator, do not permit compliance with the protocol.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
SHR-1210 plus Anlotinib
|
SHR-1210: a novel anti-PD-1 antibody Anlotinib: a multi-kinase inhibitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR based on RECIST v1.1
Time Frame: 12 months
|
Objective response rate based on RECIST v1.1 by investigators
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DCR based on RECIST v1.1
Time Frame: 12 months
|
Disease control rate based on RECIST v1.1 by investigators
|
12 months
|
Overall survival
Time Frame: 24 months
|
Overall survival based on RECIST v1.1 by investigators
|
24 months
|
Progression free survival
Time Frame: 12 months
|
Progression free survival based on RECIST v1.1 by investigators
|
12 months
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 12 months
|
Safety and tolerance by investigators
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Anticipated)
March 1, 2021
Primary Completion (Anticipated)
August 1, 2023
Study Completion (Anticipated)
August 1, 2024
Study Registration Dates
First Submitted
February 25, 2021
First Submitted That Met QC Criteria
March 11, 2021
First Posted (Actual)
March 15, 2021
Study Record Updates
Last Update Posted (Actual)
March 15, 2021
Last Update Submitted That Met QC Criteria
March 11, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
- Neoplasms, Squamous Cell
Other Study ID Numbers
- JS-2681
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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 Anlotinib
-
Tang-Du HospitalActive, not recruitingLung Cancer | Chemotherapy | Sintilimab | AnlotinibChina
-
Tianjin Medical University Cancer Institute and...Not yet recruitingNSCLC | EGFR Activating Mutation | Anlotinib | TP53 | Aumolertinib
-
Peng YuanCompletedBreast Neoplasm | Antineoplastic Agents | AnlotinibChina
-
Chinese PLA General HospitalNot yet recruitingHepatocellular Carcinoma | Anlotinib | Thermal Ablation | PDL-1China
-
Cancer Institute and Hospital, Chinese Academy...RecruitingAnlotinib | Sarcoma,Soft Tissue | Trunk | Extremity | Intensity-modulated Radiotherapy | Major Wound ComplicationsChina
-
The First People's Hospital of LianyungangChia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownLung Neoplasms | Anlotinib | Docetaxel | S-1 | PemetrexedChina
-
Shanghai Minimally Invasive Surgery CenterWithdrawnRectal Cancer | Anlotinib | Neoadjuvant Treatment
-
Shanghai Changzheng HospitalUnknownGastric Cancer | Immunotherapy | Anlotinib | Toripalimab | Gastro-oesophageal Junction CancerChina
-
Tang-Du HospitalCompletedSintilimab and Anlotinib in Combination With ChemotherapyChina
-
Ruijin HospitalRecruitingSoft Tissue Sarcoma | Radiotherapy | Anlotinib | High Risk of RecurrenceChina
Clinical Trials on SHR-1210 plus Anlotinib
-
Tianjin Medical University Cancer Institute and...Not yet recruitingEsophageal Squamous Cell Carcinoma | Progression to PD-1 AntibodyChina
-
Jiangsu HengRui Medicine Co., Ltd.Recruiting
-
The First Affiliated Hospital of Zhengzhou UniversityNot yet recruitingResectable Esophageal Squamous Cell Carcinoma
-
Qian ChuJiangsu HengRui Medicine Co., Ltd.RecruitingSarcomatoid Carcinoma of LungChina
-
Guangdong Association of Clinical TrialsNot yet recruitingNon-small Cell Lung Cancer
-
Beijing Sanbo Brain HospitalRecruitingPrimary Central Nervous System LymphomaChina
-
Jiangsu HengRui Medicine Co., Ltd.TerminatedLung NeoplasmsChina
-
Guangdong Association of Clinical TrialsUnknown
-
Harbin Medical UniversityJiangsu HengRui Medicine Co., Ltd.Unknown
-
Yanqiao ZhangNot yet recruiting