Status:
UNKNOWN
SHR-1210 in Combination With Anlotinib in Patients With Advanced or Metastatic Esophageal Squamous Cell Cancer
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
SHR-1210
Anlotinib
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 patien...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04797507
Start Date
March 1 2021
End Date
August 1 2024
Last Update
March 15 2021
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