Locally Advanced Inoperable Esophageal Squamous Cell CarcinomaPhase 2StarsNCT06422858
Sequential Tegafur-gimeracil-oteracil Potassium Capsule (s-1) and Serplulimab Following Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Serplulimab, Tegafur-gimeracil-oteracil potassium capsule(S1) and Radiotherapy in people with Locally Advanced Inoperable Esophageal Squamous Cell Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This Phase II trial evaluates the efficacy and safety of Serplulimab combined with S1 chemotherapy in patients with inoperable, locally advanced esophageal squamous cell carcinoma after concurrent chemoradiation. The primary endpoint is the one-year progression-free survival rate. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Inoperable Esophageal Squamous Cell Carcinoma
- What is being tested?
- Serplulimab, Tegafur-gimeracil-oteracil potassium capsule(S1) and Radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2024to Apr 2026
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and voluntarily sign a written informed consent form, which must be signed before initiating any study-specific procedures.
- Male or female participants aged between 18 and 70 years at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Histologically or cytologically confirmed diagnosis of locally advanced esophageal squamous cell carcinoma (ESCC); or patients who refuse surgery; staged as T1-4bN1-3M0 (according to AJCC 8th edition).
- Medically inoperable or refusal of surgery.
- No prior anti-tumor treatment.
- Expected survival of at least 6 months.
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- At least one measurable lesion as defined by RECIST v1.1.
- Participants must provide either archived (within the last 2 years) or freshly obtained tumor tissue samples, with at least three unstained FFPE pathology slides.
- Adequate organ function defined as follows:
- Hematology (no blood transfusions or growth factor support within 7 days before starting study treatment): i. Absolute Neutrophil Count (ANC) ≥1.5×10^9/L (1500/mm³); ii. Platelet count ≥100×10^9/L (100000/mm³); iii. Hemoglobin ≥90 g/L. b. Renal: i. Calculated creatinine clearance (CrCl) ≥50 mL/min using the Cockcroft-Gault formula: CrCl (mL/min) = {(140-age) × weight (kg) × F} / (SCr (mg/dL) × 72), where F=1 for males and 0.85 for females; SCr=serum creatinine.
- Urinary protein <2+ or 24-hour urinary protein quantification <1.0 g. c. Liver: i. Total bilirubin (TBiL) ≤1.5×ULN; ii. AST and ALT ≤2.5×ULN (≤5×ULN for participants with liver metastases); iii. Serum albumin (ALB) ≥28 g/L. d. Coagulation: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN, unless the participant is receiving anticoagulant therapy and INR and APTT are within the expected range of their therapeutic use.
- Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥50%.
- Female participants of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose of study medication. If urine test is not conclusive, a serum test will be administered. If sexually active with a non-sterilized male partner, the participant must agree to use effective contraception during the study and for 120 days after the last dose of study medication. Discussion with the researcher is required regarding cessation of contraception after this point.
- Male participants with female partners of childbearing potential must agree to use effective contraception from screening to 120 days after the last dose of study medication. Discussion with the researcher is required regarding cessation of contraception after this point.
- Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Previous anti-tumor treatment (including chemotherapy, radiation therapy, surgery, or immunotherapy).
- Initial diagnosis with metastases to vital organs such as the liver, bones, lungs, brain, adrenal glands, etc. (stage IVb esophageal cancer).
- History of thoracic radiotherapy.
- Presence of an esophageal mediastinal fistula and/or esophageal tracheal fistula before treatment.
- Known or suspected allergy to any component of S1, serplulimab, or cisplatin.
- Pregnant or breastfeeding women.
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- Inability to provide informed consent due to psychological, familial, or social reasons.
- History of any malignancy other than esophageal cancer within the past 5 years, except for adequately treated non-melanoma skin cancer, in-situ cervical cancer, or cured early-stage prostate cancer.
- Unable to tolerate chemoradiation due to severe cardiac, pulmonary, hepatic, renal dysfunctions, hematological diseases, or cachexia.
- Active autoimmune diseases, history of autoimmune diseases (including but not limited to colitis, hepatitis, hyperthyroidism, or syndromes), history of immunodeficiency (including positive HIV test), or other acquired or congenital immunodeficiency diseases, history of organ transplant or allogeneic bone marrow transplant.
- Active hepatitis B (HBV DNA ≥ 2000IU/mL or 10×10^4 copies/mL), positive hepatitis C antibody with elevated HCV RNA levels above the lower limit of detection.
- History of immunodeficiency; positive HIV antibody; current long-term use of systemic corticosteroids or other immunosuppressants.
- Serious infection within 4 weeks before the first administration of study medication, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective treatment within 2 weeks before the first dose (excluding antiviral treatment for hepatitis B or C).
- Known active tuberculosis (TB), suspected active TB requiring clinical exclusion; known active syphilis infection.
- Vaccination with live or attenuated live vaccines within 30 days before the first dose of study medication or planning to receive such vaccines during the study period; inactivated vaccines are permitted.
- History of interstitial lung disease or non-infectious pneumonia.
- History of myocarditis, cardiomyopathy, malignant arrhythmias, unstable angina, myocardial infarction within the past 12 months, congestive heart failure as determined by NYHA Class II or higher, or vascular diseases such as aortic aneurysm at risk of rupture, or other cardiac damage that could compromise the safety evaluation of the study medication (such as poorly controlled arrhythmia or myocardial ischemia).
- Known history of mental illness, drug abuse, alcoholism, or drug addiction.
- Non-malignant systemic diseases or symptoms secondary to tumors that could pose a higher medical risk or confound the assessment of survival, such as leukemic reaction (white cell count >20×10^9/L) or cachexia manifestations (known weight loss exceeding 10% in the 3 months prior to screening).
- Any condition that, in the opinion of the investigator, might pose a risk to the participant, interfere with the evaluation of the study medication, or confound the interpretation of study results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Jin Wang, MD, 0086-571-88122088, duxianghui88@yahoo.com.cn
Yongling JI, MD, 0086-571-88122088, drjyl@msn.com
About this study
Official title: Sequential Tegafur-gimeracil-oteracil Potassium Capsule (s-1) and Serplulimab Following Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Inoperable Esophageal Squamous Cell Carcinoma: A Single-Arm Phase II Clinical Trial
This Phase II trial evaluates the efficacy and safety of Serplulimab combined with S1 chemotherapy in patients with inoperable, locally advanced esophageal squamous cell carcinoma after concurrent chemoradiation. The primary endpoint is the one-year progression-free survival rate. Secondary measures include clinical response rates, overall survival, duration of response, and safety profiles. Exploratory goals focus on the potential of biomarkers like PD-L1 and ctDNA to predict treatment outcomes. Treatment involves initial chemoradiation followed by consolidation with Serplulimab and S1, continuing for up to 12 months or until disease progression or unacceptable toxicity.
Read the detailed description
Detailed Description:
This single-arm, Phase II study is designed to assess the efficacy and safety of the combination of Serplulimab (an anti-PD-1 antibody) and S1 (an oral fluoropyrimidine derivative) in patients with locally advanced, inoperable esophageal squamous cell carcinoma (ESCC), following concurrent chemoradiation therapy.
Study Treatment Regimen:
Patients enrolled in the study will first undergo concurrent chemoradiation, which includes a total radiation dose of 50.4 Gy delivered in 28 fractions over six weeks. Radiation will be administered using modern techniques such as image-guided radiation therapy (IGRT), intensity-modulated radiation therapy (IMRT), volumetric modulated arc therapy (VMAT), or helical tomotherapy (TOMO), ensuring precise targeting of the tumor and surrounding lymph nodes. Concurrent chemotherapy consists of cisplatin (75 mg/m2 on day 1) and S1 (60 mg/m2 per day, given in two divided doses from day 1 to day 14, repeated every 28 days).
Following chemoradiation, patients will receive consolidation therapy with Serplulimab administered at a fixed dose of 300 mg every three weeks via intravenous infusion, alongside S1 (60 mg/m2 per day, on days 1-14 of a 21-day cycle). This consolidation phase will continue for up to 12 months or 17 cycles, unless there is disease progression, patient withdrawal, onset of unacceptable toxicity, or initiation of new anti-cancer treatment.
- Being tested
- Serplulimab, Tegafur-gimeracil-oteracil potassium capsule(S1), Radiotherapy, Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
Serplulimab will be administered as a fixed dose of 300 mg via intravenous infusion every three weeks, continuing for up to 12 months or until disease progression, unacceptable toxicity, or withdrawal of consent
Tegafur-gimeracil-oteracil potassium capsule(S1)Drug
S1 will be administered at a dose of 60 mg/m2 per day, taken orally in two divided doses on day 1 concurrent with radiotherapy, repeated every 28 days; and from day 1 to day 14 of each 21-day cycle, for up to 12 months or until disease progression, unacceptable toxicity, or withdrawal of consent
RadiotherapyRadiation
Radiotherapy will be delivered as a total dose of 50.4 Gy in 28 fractions over six weeks using techniques such as IGRT, IMRT, VMAT, or TOMO, targeting the primary tumor and associated lymph nodes
CisplatinDrug
Cisplatin will be administered at a dose of 75 mg/m^2 on day 1 concurrent with radiotherapy, repeated every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab and S1 Chemotherapy Post-Concurrent Chemoradiation | Experimental | Not described Receives: Drug: Serplulimab; Drug: Tegafur-gimeracil-oteracil potassium capsule(S1); Radiation: Radiotherapy; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-Year Progression-Free Survival (PFS)
The primary outcome measure is the proportion of participants who are alive and free from disease progression at one year after initiating treatment. Progression is defined according to RECIST v1.1 criteria as a 20% increase in the sum of diameters of target lesions, the appearance of new lesions, or the worsening of non-target disease
Measured: 1 year
Secondary outcomes (5)
Incidence of Clinical Complete Response Rate (cCR) at 3 months after treatment initiation
The rate of participants achieving a clinical complete response assessed by RECIST v1.1 criteria. A clinical complete response is defined as the disappearance of all target lesions and normalization of tumor marker levels.
Measured: Assessed at 3 months after treatment initiation
Overall Survival (OS)
Overall survival is defined as the time from the start of treatment to the date of death from any cause. If a patient is not known to have died, survival time will be censored at the date of the last known follow-up.
Measured: From the start of treatment up to 3 years
Duration of Response (DoR)
Duration of response is measured from the time measurement criteria are first met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
Measured: From the first documented response up to 2 years
Incidence of Treatment-Emergent Adverse Events
The incidence and severity of adverse events categorized by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: Throughout the study, estimated at 12 months
EORTC-QoL-C30 Score(Quality of Life)
Qualitasured using validated instruments such as the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30). The quality of life score is calculated based on the rules set by EORTC (range 0-100). A lower score indicates better quality of life on the symptom scales, while a higher score indicates better quality of life scores on the overall health and functional scales.
Measured: At baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start20 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Inoperable Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Yongling, Zhejiang Cancer Hospital
- Investigators
- Yongling Ji, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422858
- Sponsor's protocol ID
- STARS-CCRT-ESCC
- Acronym
- Stars
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Tegafur-gimeracil-oteracil Potassium Capsule (s-1) and Serplulimab Following Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Inoperable Esophageal Squamous Cell Carcinoma: A Single-Arm Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06422858
- Acronym / sponsor ID
- Stars / STARS-CCRT-ESCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase II trial evaluates the efficacy and safety of Serplulimab combined with S1 chemotherapy in patients with inoperable, locally advanced esophageal squamous cell carcinoma after concurrent chemoradiation. The primary endpoint is the one-year progression-free survival rate. Secondary measures include clinical response rates, overall survival, duration of response, and safety profiles. Exploratory goals focus on the potential of biomarkers like PD-L1 and ctDNA to predict treatment outcomes. Treatment involves initial chemoradiation followed by consolidation with Serplulimab and S1, continuing for up to 12 months or until disease progression or unacceptable toxicity.
Detailed description
Detailed Description:
This single-arm, Phase II study is designed to assess the efficacy and safety of the combination of Serplulimab (an anti-PD-1 antibody) and S1 (an oral fluoropyrimidine derivative) in patients with locally advanced, inoperable esophageal squamous cell carcinoma (ESCC), following concurrent chemoradiation therapy.
Study Treatment Regimen:
Patients enrolled in the study will first undergo concurrent chemoradiation, which includes a total radiation dose of 50.4 Gy delivered in 28 fractions over six weeks. Radiation will be administered using modern techniques such as image-guided radiation therapy (IGRT), intensity-modulated radiation therapy (IMRT), volumetric modulated arc therapy (VMAT), or helical tomotherapy (TOMO), ensuring precise targeting of the tumor and surrounding lymph nodes. Concurrent chemotherapy consists of cisplatin (75 mg/m2 on day 1) and S1 (60 mg/m2 per day, given in two divided doses from day 1 to day 14, repeated every 28 days).
Following chemoradiation, patients will receive consolidation therapy with Serplulimab administered at a fixed dose of 300 mg every three weeks via intravenous infusion, alongside S1 (60 mg/m2 per day, on days 1-14 of a 21-day cycle). This consolidation phase will continue for up to 12 months or 17 cycles, unless there is disease progression, patient withdrawal, onset of unacceptable toxicity, or initiation of new anti-cancer treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab and S1 Chemotherapy Post-Concurrent Chemoradiation | Experimental | Drug: Serplulimab, Drug: Tegafur-gimeracil-oteracil potassium capsule(S1), Radiation: Radiotherapy, Drug: Cisplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Able to understand and voluntarily sign a written informed consent form, which must be signed before initiating any study-specific procedures.
- Male or female participants aged between 18 and 70 years at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Histologically or cytologically confirmed diagnosis of locally advanced esophageal squamous cell carcinoma (ESCC); or patients who refuse surgery; staged as T1-4bN1-3M0 (according to AJCC 8th edition).
- Medically inoperable or refusal of surgery.
- No prior anti-tumor treatment.
Key exclusion criteria (20 listed)
- Previous anti-tumor treatment (including chemotherapy, radiation therapy, surgery, or immunotherapy).
- Initial diagnosis with metastases to vital organs such as the liver, bones, lungs, brain, adrenal glands, etc. (stage IVb esophageal cancer).
- History of thoracic radiotherapy.
- Presence of an esophageal mediastinal fistula and/or esophageal tracheal fistula before treatment.
- Known or suspected allergy to any component of S1, serplulimab, or cisplatin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SerplulimabSerplulimab will be administered as a fixed dose of 300 mg via intravenous infusion every three weeks, continuing for up to 12 months or until disease progression, unacceptable toxicity, or withdrawal of consent | Drug | Serplulimab and S1 Chemotherapy Post-Concurrent Chemoradiation |
| Tegafur-gimeracil-oteracil potassium capsule(S1)S1 will be administered at a dose of 60 mg/m2 per day, taken orally in two divided doses on day 1 concurrent with radiotherapy, repeated every 28 days; and from day 1 to day 14 of each 21-day cycle, for up to 12 months or until disease progression, unacceptable toxicity, or withdrawal of consent | Drug | Serplulimab and S1 Chemotherapy Post-Concurrent Chemoradiation |
| RadiotherapyRadiotherapy will be delivered as a total dose of 50.4 Gy in 28 fractions over six weeks using techniques such as IGRT, IMRT, VMAT, or TOMO, targeting the primary tumor and associated lymph nodes | Radiation | Serplulimab and S1 Chemotherapy Post-Concurrent Chemoradiation |
| CisplatinCisplatin will be administered at a dose of 75 mg/m^2 on day 1 concurrent with radiotherapy, repeated every 28 days | Drug | Serplulimab and S1 Chemotherapy Post-Concurrent Chemoradiation |
Primary outcome
One-Year Progression-Free Survival (PFS)
Time frame: 1 year
The primary outcome measure is the proportion of participants who are alive and free from disease progression at one year after initiating treatment. Progression is defined according to RECIST v1.1 criteria as a 20% increase in the sum of diameters of target lesions, the appearance of new lesions, or the worsening of non-target disease
5 secondary outcomes
Incidence of Clinical Complete Response Rate (cCR) at 3 months after treatment initiation
Time frame: Assessed at 3 months after treatment initiation
Overall Survival (OS)
Time frame: From the start of treatment up to 3 years
Duration of Response (DoR)
Time frame: From the first documented response up to 2 years
Incidence of Treatment-Emergent Adverse Events
Time frame: Throughout the study, estimated at 12 months
EORTC-QoL-C30 Score(Quality of Life)
Time frame: At baseline, 6 months, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongling Ji principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab, Tegafur-gimeracil-oteracil potassium capsule(S1) and Radiotherapy in people with Locally Advanced Inoperable Esophageal Squamous Cell Carcinoma, run by Zhejiang Cancer Hospital at 1 site 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 15 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Wang, Dr (86-571-88122564, wangjin@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-Year Progression-Free Survival (PFS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2025.