A Study of CS1001 in Subjects With Esophageal Squamous Cell Carcinoma
A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of CS1001 in Combination With Fluorouracil and Cisplatin (FP) Compared to Placebo in Combination With FP as First-Line Therapy in Subjects With Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
1 other identifier
interventional
540
1 country
72
Brief Summary
Phase III Study to Investigate the Efficacy and Safety of CS1001 or Placebo in Combination with FP as First-Line Therapy in Subjects with Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2019
Typical duration for phase_3
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2019
CompletedFirst Posted
Study publicly available on registry
December 5, 2019
CompletedStudy Start
First participant enrolled
December 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2022
CompletedNovember 24, 2023
November 1, 2023
2.8 years
December 3, 2019
November 22, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by BICR, or death due to any cause, whichever occurred first.
Approximately 43 months from the time of randomization
Overall survival (OS)
OS was defined as the time from randomization to death due to any cause.
Approximately 43 months from the time of randomization
Secondary Outcomes (3)
PFS assessed by investigators according to RECIST v1.1
Approximately 43 months from the time of randomization
Objective response rate (ORR) assessed by BICR and investigators according to RECIST v1.1
Approximately 43 months from the time of randomization
Duration of response (DoR) assessed by BICR and investigators according to RECIST v1.1
Approximately 43 months from the time of randomization
Study Arms (2)
CS1001+ Fluorouracil+Cisplatin
EXPERIMENTALPlacebo+ Fluorouracil+Cisplatin
ACTIVE COMPARATORInterventions
CS1001 1200 mg, intravenous infusion on the first day of each cycle (3 weeks) (Q3W). Fluorouracil: 800 mg/m2/day, continuous intravenous infusion on Day 1 to Day 4 of each cycle Cisplatin: 80 mg/m2, intravenous infusion on the first day of each cycle.
Placebo 1200 mg, intravenous infusion on the first day of each cycle (3 weeks) (Q3W). Fluorouracil: 800 mg/m2/day, continuous intravenous infusion on Day 1 to Day 4 of each cycle Cisplatin: 80 mg/m2, intravenous infusion on the first day of each cycle.
Eligibility Criteria
You may qualify if:
- ≥ 18 years and ≤ 75 years on the day of signing informed consent form (ICF).
- Fully informed of the study, with good compliance and willing to provide written ICF. The ICF must be signed before performing any protocol-related procedure (that is not a part of subject's routine medical care).
- Subjects with pathohistologically or cytologically confirmed unresectable locally advanced, relapsed or metastatic ESCC (based on American Joint Committee on Cancer \[AJCC\] Guideline version 8, see Appendix 14.2)
- Subjects must not be eligible for radical therapy such as radical chemoradiotherapy or surgery.
- Subjects who have not received any systemic anti-neoplastic therapy as the main regimen for locally advanced or metastatic ESCC. (Subjects who received prior neoadjuvant, adjuvant or radical chemoradiotherapy for ESCC but had relapse or progression of disease 6 months after the completion of these treatments are allowed.)
- ECOG PS 0 or 1.
- Life expectancy ≥ 3 months.
- Subjects have at least one measurable lesion as evaluated by the investigator according to RECIST v1.1, and the baseline imaging assessment must be performed within 28 days prior to the first dose of investigational product. Target lesions in the past radiation fields, if confirmed as radiological progression, are considered as measurable lesions.
- Palliative treatment (e.g. radiotherapy) for local lesion must be completed ≥ 14 days prior to the first dose of investigational product.
- Subjects must provide tumor tissue samples (formalin fixed-paraffin embedded \[FFPE\] tissue block or unstained tumor tissue sections) for biomarker analysis, in order to determine the expression of PD-L1.
- Subjects must have adequate organ function as assessed in the following laboratory tests (subjects must not receive any blood transfusion or any hematopoietic growth factor within 7 days prior to the test)
- Female subjects with childbearing potential (unless with documentation of sterilization surgery or being post-menopausal) must have negative serum pregnancy test result at screening. Female subject with childbearing potential (unless with documentation of sterilization surgery or being post-menopausal) or male subjects and their partners must agree to use an effective contraceptive measure from the day of signing ICF till at least 6 months after the last dose of investigational product.
You may not qualify if:
- Adenocarcinoma, mixture of adenocarcinoma and squamous cell carcinoma, or other pathological type of esophageal cancer.
- Subjects with active central nervous system (CNS) metastasis and/or carcinomatous meningitis (that is symptomatic, or requires treatment, or no radiological evidence confirming the stability of the lesion within 28 days prior to the first dose of investigational product).
- With another active primary malignancy in the past 5 years, except local curable cancers that have undergone curative therapy, e.g. basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, prostate cancer in situ, breast cancer in situ or cervical cancer in situ.
- Known history of positive human immunodeficiency virus (HIV) test result or acquired immunodeficiency syndrome (AIDS).
- Any severe or uncontrolled systemic disease, e.g., diabetes mellitus or hypertension, that may increase the risk associated with participation in the study or investigational product administration, or compromise subject's ability to receive investigational product, as per investigator's judgment.
- Subjects who have previously received any treatment of antibody or drug that targets at T-cell coregulatory pathways or immune checkpoint pathways, e.g., antibodies targeting at programmed death receptor-1 (PD-1), programmed death receptor-ligand 1 (PD-L1), cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), OX-40, CD137, T cell immunoglobulin mucin molecule 3 (TIM-3), lymphocyte activation gene 3 (LAG-3), etc. Subjects who have received cell-based immunotherapy (e.g., cytokine-induced killer cell \[CIK\], chimeric antigen receptor T cell \[CAR-T\] immunotherapy, etc.).
- All toxicities except for alopecia and fatigue that are caused by the prior anti-neoplastic treatment has recovered to Grade 1 (according to National Cancer Institute Common Toxicity Criteria for Adverse Events \[NCI CTCAE\] v5.0).
- Subjects with history of allogenic stem cell or solid organ transplantation.
- Subjects with any condition that in the investigator's opinion are not suitable for participating in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
Hefei Second People's Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Peaking University International Hospital
Beijing, Beijing Municipality, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, China
Special Medical Center of The People's Liberation Army of China
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Jieyang People's Hospital
Jieyang, Guangdong, China
Affiliated Tumor Hospital of Shantou University Medical College
Shantou, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat sen University
Zhuhai, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
Hainan General Hospital
Haikou, Hainan, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
Handan Central Hospital
Handan, Hebei, China
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
The Affiliated Tumor Hospital of Harbin Meidical University
Haerbin, Heilongjiang, China
Anyang Cancer Hospital
Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
Nanyang First People's Hospital
Nanyang, Henan, China
Puyang Oilfield General Hospital
Puyang, Henan, China
Xinxiang First People's Hospital
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Tongji Medical College of HUST, Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Wuhan Fifth Hospital
Wuhan, Hubei, China
Wuhan Union Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Changzhou Tumor Hospital
Changzhou, Jiangsu, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Tonghua Central Hospital
Tonghua, Jilin, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Jinan central Hospital
Jinan, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 201203, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Linfen Central Hospital
Linfen, Shanxi, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Chengdu Fifith people's hospital
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
Yibin Second People's Hospital
Yibin, Sichuan, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Cancer Hospital Affiliated to Xinjiang Medical University
Ürümqi, Xinjiang, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Related Publications (1)
Li J, Chen Z, Bai Y, Liu B, Li Q, Zhang J, Zhou J, Deng T, Zhou F, Gao S, Yang S, Ye F, Chen L, Bai W, Yin X, Cang S, Liu L, Pan Y, Luo H, Ji Y, Zhang Z, Wang J, Yang Q, Li N, Huang R, Qu C, Ni J, Wang B, Xu Y, Hu J, Shi Q, Yang J. First-line sugemalimab with chemotherapy for advanced esophageal squamous cell carcinoma: a randomized phase 3 study. Nat Med. 2024 Mar;30(3):740-748. doi: 10.1038/s41591-024-02797-y. Epub 2024 Feb 1.
PMID: 38302715DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2019
First Posted
December 5, 2019
Study Start
December 19, 2019
Primary Completion
October 7, 2022
Study Completion
October 7, 2022
Last Updated
November 24, 2023
Record last verified: 2023-11