SHR-1210 in Combination With Anlotinib in Patients With Advanced or Metastatic Esophageal Squamous Cell Cancer

NCT04797507 | Unknown Phase 2

• 1 other identifier: JS-2681
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

SHR-1210; Anlotinib; Advanced Esophageal Squamous Cell Cancer

Outcome Measures

Primary Outcomes (1)

• ORR based on RECIST v1.1

  Objective response rate based on RECIST v1.1 by investigators

  12 months

Secondary Outcomes (4)

• 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

Study Arms (1)

Treatment Group

EXPERIMENTAL

SHR-1210 plus Anlotinib

Drug: SHR-1210 plus Anlotinib

Interventions

SHR-1210 plus Anlotinib DRUG

SHR-1210: a novel anti-PD-1 antibody Anlotinib: a multi-kinase inhibitor

Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Interventions

camrelizumab; anlotinib

Central Study Contacts

Junjie Gu, Doctor

CONTACT

86-10-69158773; gujunjie_ella@126.com

Chunmei Bai, Doctor

CONTACT

86-10-69158773; baichunmei1964@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 15, 2021
• Study Start: March 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: March 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share