---
title: Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma
nct_id: NCT05461794
overall_status: TERMINATED
phase: PHASE2
sponsor: BeiGene
study_type: INTERVENTIONAL
primary_condition: Esophageal Squamous Cell Carcinoma
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05461794.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05461794"
ct_last_update_post_date: 2025-06-13
last_seen_at: "2026-05-12T07:07:35.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT05461794](https://clinicaltrials.gov/study/NCT05461794)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Due to modification of company strategy.
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 96
- **Lead Sponsor:** BeiGene
- **Conditions:** Esophageal Squamous Cell Carcinoma
- **Start Date:** 2022-10-03
- **Completion Date:** 2024-02-26
- **CT.gov Last Update:** 2025-06-13

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Arm A: Tislelizumab + Sitravatinib** (EXPERIMENTAL) — Sitravatinib administered orally and tislelizumab administered intravenously
- **Arm B: Sitravatinib** (EXPERIMENTAL) — Sitravatinib administered orally
- **Arm C: Investigator-chosen chemotherapy (ICC)** (EXPERIMENTAL) — Investigators chose between docetaxel or irinotecan

## Interventions

- **Sitravatinib** (DRUG) — 100 mg orally once daily
- **Tislelizumab** (DRUG) — 200 mg intravenously once every 3 weeks
- **Docetaxel** (DRUG) — 75 milligrams per square meter of body surface area (mg/m2) intravenously on Day 1 of every 21-day cycle
- **Irinotecan** (DRUG) — 125 mg/m2 intravenously on Days 1 and 8 of every 21-day cycle

## Primary Outcomes

- **Arms A and C: Overall Response Rate (ORR)** _(time frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))_ — ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1.

## Secondary Outcomes

- **Duration of Response (DOR)** _(time frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))_
- **Overall Survival (OS)** _(time frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))_
- **Disease Control Rate (DCR)** _(time frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))_
- **Clinical Benefit Rate (CBR)** _(time frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))_
- **Progression Free Survival (PFS)** _(time frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))_
- **Arms A and B: Overall Response Rate (ORR)** _(time frame: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months))_
- **Number of Participants With Adverse Events** _(time frame: 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).)_

## Locations (31)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.anhui provincial hospital south brance|hefei|anhui|china` — added _(2026-05-12)_
- `locations.anhui provincial cancer hospital aka west branch of anhui province hospital|hefei|anhui|china` — added _(2026-05-12)_
- `locations.beijing friendship hospital, capital medical university|beijing|beijing municipality|china` — added _(2026-05-12)_
- `locations.beijing cancer hospital|beijing|beijing municipality|china` — added _(2026-05-12)_
- `locations.beijing luhe hospital, capital medical university|beijing|beijing municipality|china` — added _(2026-05-12)_
- `locations.the first affiliated hospital of fujian medical university|fuzhou|fujian|china` — added _(2026-05-12)_
- `locations.fujian cancer hospital|fuzhou|fujian|china` — added _(2026-05-12)_
- `locations.sun yat sen university cancer center|guangzhou|guangdong|china` — added _(2026-05-12)_
- `locations.sun yat sen university cancer center(huangpu campus)|guangzhou|guangdong|china` — added _(2026-05-12)_
- `locations.cancer hospital of shantou university medical college|shantou|guangdong|china` — added _(2026-05-12)_
- `locations.the tumor hospital affiliated to guangxi medical university|nanning|guangxi|china` — added _(2026-05-12)_
- `locations.harbin medical university cancer hospital|harbin|heilongjiang|china` — added _(2026-05-12)_
- `locations.the first affiliated hospital of xinxiang medical university|xinxiang|henan|china` — added _(2026-05-12)_
- `locations.henan cancer hospital|zhengzhou|henan|china` — added _(2026-05-12)_
- `locations.the first affiliated hospital of zhengzhou university|zhengzhou|henan|china` — added _(2026-05-12)_
- `locations.union hospital of tongji medical college, huazhong university of science and technology|wuhan|hubei|china` — added _(2026-05-12)_
- `locations.xiangyang central hospital|xiangyang|hubei|china` — added _(2026-05-12)_
- `locations.hunan cancer hospital|changsha|hunan|china` — added _(2026-05-12)_
- `locations.northern jiangsu peoples hospital|yangzhou|jiangsu|china` — added _(2026-05-12)_
- `locations.ganzhou peoples hospital ganzhou hospital affiliated to nanchang university|ganzhou|jiangxi|china` — added _(2026-05-12)_
- `locations.the first affiliated hospital of nanchang university branch donghu|nanchang|jiangxi|china` — added _(2026-05-12)_
- `locations.jilin cancer hospital|changchun|jilin|china` — added _(2026-05-12)_
- `locations.liaoning cancer hospital and institute|shenyang|liaoning|china` — added _(2026-05-12)_
- `locations.shandong cancer hospital|jinan|shandong|china` — added _(2026-05-12)_
- `locations.weifang peoples hospital|weifang|shandong|china` — added _(2026-05-12)_
- `locations.rui jin hospital shanghai jiao tong university school of medicine|shanghai|shanghai municipality|china` — added _(2026-05-12)_
- `locations.affiliated zhongshan hospital of fudan university|shanghai|shanghai municipality|china` — added _(2026-05-12)_
- `locations.west china hospital, sichuan university|chengdu|sichuan|china` — added _(2026-05-12)_
- `locations.sichuan academy of medical sciences and sichuan provincial peoples hospital|chengdu|sichuan|china` — added _(2026-05-12)_
- `locations.tianjin medical university general hospital|tianjin|tianjin municipality|china` — added _(2026-05-12)_
- `locations.zhejiang cancer hospital|hangzhou|zhejiang|china` — added _(2026-05-12)_

---

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