Clinical trial NCT05461794: Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: esophageal squamous cell carcinoma
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to evaluate the efficacy and safety of sitravatinib in combination with tislelizumab as a second- or third-line treatment for participants with locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) who experienced disease progression following prior systemic chemotherapy.


Eligibility criteria: 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 Response Evaluation Criteria in Solid Tumors (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. Eastern Cooperative Oncology Group (ECOG) 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. Participants 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. Participants 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, receptor tyrosine kinases (RTKs) with a similar target profile or Vascular Endothelial Growth Factor (VEGF)/Vascular Endothelial Growth Factor Receptor-targeted (VEGFR) monoclonal antibodies)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Arms A and C: Overall Response Rate (ORR)
timeFrame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
measure: Overall Survival (OS)
timeFrame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
measure: Disease Control Rate (DCR)
timeFrame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
measure: Clinical Benefit Rate (CBR)
timeFrame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
measure: Progression Free Survival (PFS)
timeFrame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
measure: Arms A and B: Overall Response Rate (ORR)
timeFrame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
measure: Number of Participants With Adverse Events
timeFrame: From the first dose to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital South Brance
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center(Huangpu Campus)
state: Guangdong
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
state: Guangdong
city: Nanning
country: China
facility: The Tumor Hospital Affiliated to Guangxi Medical University
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Yangzhou
country: China
facility: Northern Jiangsu Peoples Hospital
state: Jiangsu
city: Ganzhou
country: China
facility: Ganzhou Peoples Hospital Ganzhou Hospital Affiliated to Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University Branch Donghu
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang Peoples Hospital
state: Shandong
city: Shanghai
country: China
facility: Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Affiliated Zhongshan Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: