Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

A Phase 2, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Patients With Locally Advanced Unresectable or Metastatic Esophageal Squamous Cell Carcinoma That Progressed on or After Anti-PD-(L)1 Antibody Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05461794
• Other study ID #: BGB-A317-Sitravatinib-203
• Secondary ID: CTR20222088
• Status: Terminated
• Phase: Phase 2
• Start date: October 3, 2022
• Est. completion date: February 26, 2024

Study information

• Verified date: November 2023
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy and safety of sitravatinib in combination with tislelizumab for the treatment of participants with esophageal squamous cell carcinoma

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: February 26, 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Histologically or cytologically confirmed locally advanced unresectable or metastatic ESCC, not amenable to treatment with curative intent

2. At least 1 measurable lesion as defined per RECIST v1.1 as determined by local site investigator/radiology assessment = 28 days before randomization Note: Lesions that had been previously irradiated were considered evaluable provided

3. ECOG PS score = 1

4. Adequate organ function as indicated by the following laboratory values as indicated by the laboratory tests performed = 7 days before randomization

Key Exclusion Criteria:

1. Have any contraindication for receiving treatment with both docetaxel and irinotecan

2. Patients with tumor located around important vascular structures as shown by imaging or the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding (ie, radiologic evidence of tumors invading or abutting major blood vessels)

3. Patients with tumor that invades into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) that has an increased risk of fistula during the study treatment period as assessed by the investigator

4. . History of gastrointestinal perforation and/or fistula or aorto-esophageal fistula within 6 months before randomization

5. Have received prior anticancer agents that have same mechanism of action as sitravatinib (eg, RTK inhibitor with a similar target profile or VEGF- or VEGFR-targeted monoclonal antibodies) ther protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Sitravatinib
administered orally
• Tislelizumab
administered intravenously
• Docetaxel
administered intravenously
• Irinotecan
administered intravenously

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Luhe Hospital, Capital Medical University	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital	Chengdu	Sichuan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University	Ganzhou	Jiangxi
China	Sun Yat Sen University Cancer Center	Guangzhou	Guangdong
China	Sun Yat Sen University Cancer Center(Huangpu Campus)	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital	Hefei	Anhui
China	Anhui Provincial Hospital South Brance	Hefei	Anhui
China	Shandong Cancer Hospital	Jinan	Shandong
China	The Tumor Hospital Affiliated to Guangxi Medical University	Nanning	Guangxi
China	Affiliated Zhongshan Hospital of Fudan University	Shanghai	Shanghai
China	Rui Jin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Cancer Hospital of Shantou University Medical College	Shantou	Guangdong
China	Liaoning Cancer Hospital and Institute	Shenyang	Liaoning
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Union Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Xiangyang Central Hospital	Xiangyang	Hubei
China	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	Northern Jiangsu Peoples Hospital	Yangzhou	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arms A and C: Overall Response Rate (ORR)	ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	Up to 2 Years
Secondary	Duration of Response (DOR)	defined as the time from the first confirmed objective response until the first documentation of disease progression or death, whichever comes first	Up to 2 Years
Secondary	Arms A and C: Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of death due to any cause	Up to 2 Years
Secondary	Disease Control Rate (DCR)	DCR is defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	Up to 2 Years
Secondary	Clinical Benefit Rate (CBR)	CBR is defined as the percentage of participants who have complete response, partial response, and stable disease, as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	Up to 2 Years
Secondary	Progression Free Survival (PFS)	PFS is defined as the time from the date of randomization until first documentation of progression or death, whichever comes first, as assessed by the investigator Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	Up to 2 Years
Secondary	Overall Response Rate (ORR) as assessed by the investigator	defined as the proportion of patients with a confirmed complete response or partial response per RECIST v1.1	Up to 2 Years
Secondary	Number of participants with adverse events (AEs)	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	Up to 2 Years
Secondary	Number of participants with clinically significant changes from baseline in clinical laboratory values	Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis	Up to 2 Years
Secondary	Number of participants with clinically significant changes from baseline in vital signs	Vital signs include blood pressure and pulse rate	Up to 2 Years