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

Peking Union Medical College Hospital0 sites33 target enrollmentMarch 2021

ConditionsSHR-1210 Anlotinib Advanced Esophageal Squamous Cell Cancer

InterventionsSHR-1210 plus Anlotinib

DrugsSHR-1210 plus Anlotinib

Overview

Phase: Phase 2
Intervention: SHR-1210 plus Anlotinib
Conditions: SHR-1210
Sponsor: Peking Union Medical College Hospital
Enrollment: 33
Primary Endpoint: ORR based on RECIST v1.1
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

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.

Registry

clinicaltrials.gov

Start Date

March 2021

End Date

August 2024

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Sponsor

Eligibility Criteria

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.

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.
•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.

Arms & Interventions

Treatment Group

SHR-1210 plus Anlotinib

Intervention: SHR-1210 plus Anlotinib

Outcomes

Primary Outcomes

ORR based on RECIST v1.1

Time Frame: 12 months

Objective response rate based on RECIST v1.1 by investigators

Secondary Outcomes

DCR based on RECIST v1.1(12 months)
Overall survival(24 months)
Progression free survival(12 months)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(12 months)