Esophageal Squamous Cell CarcinomaEarly Phase 1NCT03940001
A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer
A Early Phase 1 study testing Sintilimab, carboplatin/paclitaxel and Radiation in people with Esophageal Squamous Cell Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study is to test the the efficacy and safety of sintilimab in combination with chemoradiation before surgery for esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Sintilimab, carboplatin/paclitaxel and Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 1 May 2022
- Phase
- Early Phase 1
- 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
- Histologically or cytologically confirmed esophageal squamous carcinoma
- 18≤age≤75
- ECOG PS is 0-1
- TanyN+M0 or T3-4NanyM0 tumors
- Patients must have surgically resectable disease treatable by esophagectomy, as assessed by a thoracic surgeon
- No prior chemotherapy,radiotherapy and immunotherapy
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- Disease must be clinically limited to the esophagus
- No esophageal perforation and no active esophageal bleeding
- No interstitial pneumonia or history of interstitial pneumonia
- FEV1>1.2L
- Adequate organ function defined at baseline as: WBC ≥3,000/ L，ANC ≥1,500/ L，Platelets ≥100,000/ L，Hb ≥9 g/dl； Calculated creatinine clearance >40 ml/min using Cockcroft-Gault method: Males: Creatinine CL = Weight (kg) x (140 - Age) . (mL/min) 72 x serum creatinine (mg/dL)Female：Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)；Total serum bilirubin ≤1.5 mg/dL， AST/ALT ≤2.5× upper limit of normal，Mean QT interval corrected for heart rate (QTc) <470 ms calculated from 3 ECGs using Frediricia's Correction
- Able to provide written informed consent
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Who cannot join
- Previous treatment with chemotherapy, radiotherapy or immunotherapy
- Cervical esophageal cancer
- Esophageal perforation or active esophageal bleeding
- Interstitial pneumonia or history of interstitial pneumonia
- Patients with evidence of metastatic disease
- Chronic Hepatitis B or C infection (e.g. Hepatitis B surface Ag positive or detectable viral load for Hepatitis B or C). Patients with prior evidence of Hepatitis B or C without active infection are eligible
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- Autoimmune diseases (such as systemic lupus erythematosus, rheumatoid rthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next stage of screening: type I diabetes, skin diseases without systemic treatment (such as vitiligo, psoriasis)
- 14 days before the first dose, the patient had an active infection that required systemic treatment
- Inability to understand or may not comply with test requirements
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Ming Chen, M.D., 0086-571-88122068, chenming@zjcc.org.cn
About this study
Official title: A Study of Anti-PD-1 Antibody, Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer
The purpose of this study is to test the the efficacy and safety of sintilimab in combination with chemoradiation before surgery for esophageal cancer.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Sintilimab, carboplatin/paclitaxel, Radiation
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabBiological
Other Name: (IBI308)
carboplatin/paclitaxelDrug
carboplatin AUC 2/paclitaxel 50 mg/m2 weekly
RadiationRadiation
IMRT or VMAT
| Study group | Role | What they receive |
|---|---|---|
| arm | Experimental | Biological: Sintilimab For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
Drug: Paclitaxel 50 mg/m^2 IV Q3W day 1, day 8 and day 15
Drug: carboplatin AUC: 2 IV Q3W day 1, day 8 and day 15
Radiotherapy:
1.8 Gy/fraction ×23 fractions Monday to Friday total dose of 41.4 Gy Receives: Biological: Sintilimab; Drug: carboplatin/paclitaxel; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
unacceptable toxicity
"Unacceptable toxicity" is defined as any of the following toxicities: >1 episode of grade 3/4 neutropenia or thrombocytopenia <75,000/μL (despite prior dose reduction) during chemoradiation any toxicity that results in >2 week cumulative delay in chemoradiation any toxicity that is attributed to durvalumab which results in a delay of >8 weeks in surgery, i.e. surgery >16 weeks from the end of radiation, for a potentially operable patient any reason that is attributed to durvalumab which leads to death within 30 days of surgery
Measured: 1 year
pathologic complete response rate, pCR
Measured: 1 year
major pahological response, MPR
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 May 2019
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- chen ming, MD, Principal investigator, Zhejiang Cancer Hospitalchen qixun, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940001
- Sponsor's protocol ID
- ZJCH1903
- Status last verified
- May 2019
- First submitted
- 4 May 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen D, Li R, She Y, Liu X, Huang Y, Ji Y, Chen K, Song Z, Chen R, Li X, Zhao Q, Chen Q, Chen M. PRDM1+ Malignant Cells Mediate an Immunosuppressive Landscape and Resistance to Neoadjuvant Chemoradiotherapy and Immunotherapy in Esophageal Squamous Cell Carcinoma. Adv Sci (Weinh). 2026 Mar;13(17):e15207. doi: 10.1002/advs.202515207. Epub 2026 Jan 20.
PubMed 41556358
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Anti-PD-1 Antibody, Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03940001
- Acronym / sponsor ID
- ZJCH1903
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 7 May 2019 (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.
The purpose of this study is to test the the efficacy and safety of sintilimab in combination with chemoradiation before surgery for esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm | Experimental | Biological: Sintilimab, Drug: carboplatin/paclitaxel, Radiation: RadiationBiological: Sintilimab For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1 Drug: Paclitaxel 50 mg/m^2 IV Q3W day 1, day 8 and day 15 Drug: carboplatin AUC: 2 IV Q3W day 1, day 8 and day 15 Radiotherapy: 1.8 Gy/fraction ×23 fractions Monday to Friday total dose of 41.4 Gy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically confirmed esophageal squamous carcinoma
- 18≤age≤75
- ECOG PS is 0-1
- TanyN+M0 or T3-4NanyM0 tumors
- Patients must have surgically resectable disease treatable by esophagectomy, as assessed by a thoracic surgeon
Key exclusion criteria (9 listed)
- Previous treatment with chemotherapy, radiotherapy or immunotherapy
- Cervical esophageal cancer
- Esophageal perforation or active esophageal bleeding
- Interstitial pneumonia or history of interstitial pneumonia
- Patients with evidence of metastatic disease
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 |
|---|---|---|
| SintilimabOther Name: (IBI308) | Biological | arm |
| carboplatin/paclitaxelcarboplatin AUC 2/paclitaxel 50 mg/m2 weekly | Drug | arm |
| RadiationIMRT or VMAT | Radiation | arm |
Primary outcome
unacceptable toxicity
Time frame: 1 year
"Unacceptable toxicity" is defined as any of the following toxicities: >1 episode of grade 3/4 neutropenia or thrombocytopenia <75,000/μL (despite prior dose reduction) during chemoradiation any toxicity that results in >2 week cumulative delay in chemoradiation any toxicity that is attributed to durvalumab which results in a delay of >8 weeks in surgery, i.e. surgery >16 weeks from the end of radiation, for a potentially operable patient any reason that is attributed to durvalumab which leads to death within 30 days of surgery
pathologic complete response rate, pCR
Time frame: 1 year
major pahological response, MPR
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Derived from this study: PubMed 41556358Shen D, Li R, She Y, Liu X, Huang Y, Ji Y, Chen K, Song Z, Chen R, Li X, Zhao Q, Chen Q, Chen M. PRDM1+ Malignant Cells Mediate an Immunosuppressive Landscape and Resistance to Neoadjuvant Chemoradiotherapy and Immunotherapy in Esophageal Squamous Cell Carcinoma. Adv Sci (Weinh). 2026 Mar;13(17):e15207. doi: 10.1002/advs.202515207. Epub 2026 Jan 20.
- 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.
chen ming, MD principal investigator
Zhejiang Cancer Hospital
chen qixun, MD 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 Early Phase 1 study testing Sintilimab, carboplatin/paclitaxel and Radiation in people with 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 13 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: status not confirmed, as of the sponsor's last update on 9 Sep 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 ji yongling, MD (08613958085251, jiyl@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
unacceptable toxicity (time frame: 1 year). The study lists 3 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 NCT03940001, 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 9 Sep 2019.