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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age:18 years to 75 years, male or female.
  2. Histologically or cytologically confirmed squamous cell carcinoma of the esophagus, locally advanced, unresectable, recurrent or metastatic disease.
  3. Progressed after first-line chemotherapy.
  4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
  5. Newly acquired or archived tumor tissue samples can be obtained.
  6. Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1
  7. Life expectancy >12 weeks.
  8. Adequate organ function.
  9. 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.
  10. Willing and able to follow the study protocol and follow-up procedures for treatment and follow-up.
  11. 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:

  1. 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.
  2. 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.
  3. 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.
  4. Subjects with any active, known or suspected autoimmune disease or history of autoimmune disease.
  5. Received systemic steroid therapy within 3 days of the first dose of study medication.
  6. Received a live vaccine within 4 weeks of the first dose of study medication.
  7. Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.
  8. 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.
  9. Pregnant or lactating female.
  10. Participate in other clinical trials currently or within 4 weeks prior to enrollment.
  11. Receiving other anti-cancer drugs (including anti-cancer traditional chinese medicine).
  12. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group
SHR-1210 plus Anlotinib
Drug: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College 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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings