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Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell CarcinomaPhase 3NCT04187352

A Study of CS1001 in Subjects With Esophageal Squamous Cell Carcinoma

A Phase 3 study testing CS1001+ Fluorouracil+Cisplatin in people with Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma, run by CStone Pharmaceuticals at 72 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
CS1001+ Fluorouracil+Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
540 participants
Where
72 sitesChina
Study dates
19 Dec 2019to 7 Oct 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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.
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  • 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.

Who cannot join

  • 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.).
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  • 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.

Trial locations and contacts

72 sites in 1 country.

72 sites in 1 country

China72 sites

  • Anyang Cancer Hospital

    Anyang, Henan

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality

  • Peaking University International Hospital

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

  • Jilin Cancer Hospital

    Changchun, Jilin

  • The Second Hospital of Jilin University

    Changchun, Jilin

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Changzhou Tumor Hospital

    Changzhou, Jiangsu

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei

  • Chengdu Fifith people's hospital

    Chengdu, Sichuan

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • West China Hospital Sichuan University

    Chengdu, Sichuan

  • Chongqing General Hospital

    Chongqing, Chongqing Municipality

  • Special Medical Center of The People's Liberation Army of China

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The First People's Hospital of Foshan

    Foshan, Guangdong

  • Fujian Cancer Hospital

    Fuzhou, Fujian

  • Cancer Center of Guangzhou Medical University

    Guangzhou, Guangdong

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Guangzhou, Guangdong

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • The Affiliated Tumor Hospital of Harbin Meidical University

    Haerbin, Heilongjiang

  • Hainan General Hospital

    Haikou, Hainan

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan

  • Handan Central Hospital

    Handan, Hebei

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • Anhui Provincial Hospital

    Hefei, Anhui

  • Hefei Second People's Hospital

    Hefei, Anhui

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Huai'an First People's Hospital

    Huai'an, Jiangsu

  • Jiangmen Central Hospital

    Jiangmen, Guangdong

  • Jieyang People's Hospital

    Jieyang, Guangdong

  • Jinan central Hospital

    Jinan, Shandong

  • Shandong Cancer Hospital

    Jinan, Shandong

  • Yunnan Cancer Hospital

    Kunming, Yunnan

  • Linfen Central Hospital

    Linfen, Shanxi

  • Linyi Cancer Hospital

    Linyi, Shandong

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi

  • The First Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi

  • Nanyang Central Hospital

    Nanyang, Henan

  • Nanyang First People's Hospital

    Nanyang, Henan

  • Puyang Oilfield General Hospital

    Puyang, Henan

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 201203

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality

  • Affiliated Tumor Hospital of Shantou University Medical College

    Shantou, Guangdong

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning

  • Shijiazhuang People's Hospital

    Shijiazhuang, Hebei

  • Suining Central Hospital

    Suining, Sichuan

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

  • Tonghua Central Hospital

    Tonghua, Jilin

  • Cancer Hospital Affiliated to Xinjiang Medical University

    Ürümqi, Xinjiang

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Tongji Medical College of HUST, Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei

  • Wuhan Fifth Hospital

    Wuhan, Hubei

  • Wuhan Union Hospital

    Wuhan, Hubei

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • Xinxiang First People's Hospital

    Xinxiang, Henan

  • Yibin Second People's Hospital

    Yibin, Sichuan

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • The Fifth Affiliated Hospital of Sun Yat sen University

    Zhuhai, Guangdong

Other trials in China

About this study

Official title: 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)

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

Being tested
CS1001+ Fluorouracil+Cisplatin, Placebo+ Fluorouracil+Cisplatin
Medical subject headings
Recurrence, Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CS1001+ Fluorouracil+CisplatinDrug

    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+ Fluorouracil+CisplatinDrug

    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.

Study groups in NCT04187352
Study groupRoleWhat they receive
CS1001+ Fluorouracil+CisplatinExperimentalNot described
Receives: Drug: CS1001+ Fluorouracil+Cisplatin
Placebo+ Fluorouracil+CisplatinActive comparatorNot described
Receives: Drug: Placebo+ Fluorouracil+Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Approximately 43 months from the time of randomization

  2. Overall survival (OS)

    OS was defined as the time from randomization to death due to any cause.

    Measured: Approximately 43 months from the time of randomization

Secondary outcomes (3)

  1. PFS assessed by investigators according to 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 investigators, or death due to any cause, whichever occurred first.

    Measured: Approximately 43 months from the time of randomization

  2. Objective response rate (ORR) assessed by BICR and investigators according to RECIST v1.1

    ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR) or a Partial Response (PR) per RECIST 1.1.

    Measured: Approximately 43 months from the time of randomization

  3. Duration of response (DoR) assessed by BICR and investigators according to RECIST v1.1

    DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first.

    Measured: Approximately 43 months from the time of randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2019
  2. Study start19 Dec 2019
  3. Primary completion7 Oct 2022
  4. Study completion7 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
540 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04187352
Sponsor's protocol ID
CS1001-304
Status last verified
Nov 2023
First submitted
3 Dec 2019
Last updated
24 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38302715

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CS1001+ Fluorouracil+Cisplatin in people with Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma, run by CStone Pharmaceuticals at 72 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: Approximately 43 months from the time of randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04187352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.

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