Esophageal CancerPhase 3ESO-Nanjing7NCT07306663
Sintilimab Combined With Chemotherapy Induction Therapy Followed by CCRT vs. CCRT for Esophageal Cancer: A Randomized Controlled Phase Ⅲ Clinical Study
A Phase 3 study testing Sintilimab, 3-Weekly Paclitaxel plus Carboplatin (TC) Chemotherapy and Weekly TC Chemotherapy in people with Esophageal Cancer, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
The objective of this clinical trial is to determine whether the addition of immunotherapy combined with chemotherapy before chemoradiotherapy can increase the survival rate of patients with esophageal cancer. It will also assess the safety of this regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Sintilimab, 3-Weekly Paclitaxel plus Carboplatin (TC) Chemotherapy and Weekly TC Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Voluntarily participate and provide written informed consent;
- Age 18-75 years, regardless of gender;
- Histologically or cytologically confirmed esophageal squamous cell carcinoma;
- Patients with inoperable esophageal cancer;
- Clinical stage Ⅱ-ⅣA (AJCC 8th edition esophageal cancer staging system, including stage ⅣB with supraclavicular lymph node metastasis but excluding other distant metastatic stage ⅣB);
- ECOG performance status 0-1;
- Expected survival ≥ 3 months;
- No severe dysfunction of hematopoietic, cardiac, pulmonary, hepatic, or renal systems, nor immune deficiency; Neutrophils ≥ 1.5×10⁹/L; hemoglobin ≥ 9 g/dL; platelets ≥ 100×10⁹/L; total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; creatinine ≤ 1.5 × ULN.
Who cannot join
- Esophageal perforation or hematemesis;
- Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (patients with hypothyroidism stable on hormone replacement therapy for ≥4 weeks with TSH/FT4 within normal range may be included); additionally, patients who have used immunosuppressants within 28 days will be excluded, except for steroid use for managing chemoradiation-related toxicities;
- Previous or ongoing treatment with other types of PD-1 antibodies, or prior immunotherapy targeting PD-1/PD-L1;
- Known allergic reaction to macromolecular protein drugs or sintilimab or any of its formulation components;
- Uncontrolled cardiac disease or clinical symptoms, such as: a. heart failure of NYHA class II or above; b. unstable angina; c. myocardial infarction within the past year; d. supraventricular or ventricular arrhythmias requiring clinical intervention;
- Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection), or active tuberculosis;
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- Active infection, or unexplained fever (body temperature >38.5℃) within 2 weeks prior to screening (fever judged by the investigator to be due to the tumor itself may be allowed);
- Male or female participants of childbearing potential who refuse to use contraception during the study; or female patients who are pregnant or breastfeeding;
- Other conditions judged by the investigator that may lead to premature termination of the study, such as co-existing severe diseases (including psychiatric disorders) requiring combined treatment, or family/social factors that may affect participant safety or integrity of the trial data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sintilimab Combined With Chemotherapy Induction Therapy Followed by Concurrent Chemoradiotherapy vs. Concurrent Chemoradiotherapy for Esophageal Cancer: A Randomized Controlled Phase Ⅲ Clinical Study
The objective of this clinical trial is to determine whether the addition of immunotherapy combined with chemotherapy before chemoradiotherapy can increase the survival rate of patients with esophageal cancer. It will also assess the safety of this regimen. The primary questions it aims to answer include:
- Can the addition of immunotherapy combined with chemotherapy before chemoradiotherapy reduce the rate of disease recurrence among participants?
- What adverse reactions will participants experience during the treatment process?
- Compared with traditional chemoradiotherapy, will this regimen extend the survival period of participants?
Read more
Participants will:
- Undergo two cycles of immunotherapy combined with chemotherapy, administered every three weeks, followed by concurrent chemoradiotherapy, which includes 28 sessions of radiotherapy and five sessions of chemotherapy during the concurrent period; or proceed directly to concurrent chemoradiotherapy, and then receive two cycles of chemotherapy after the completion of radiotherapy, administered once a month.
- Undergo regular tests and examinations to evaluate efficacy and safety.
- Record symptoms that occur during the treatment period.
- Conditions
- Esophageal Cancer
- Being tested
- Sintilimab, 3-Weekly Paclitaxel plus Carboplatin (TC) Chemotherapy, Weekly TC Chemotherapy, Four-Weekly TC Consolidation Chemotherapy, Definitive Radiotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabBiological
200mg, once every three weeks, administered before concurrent chemoradiotherapy.
3-Weekly Paclitaxel plus Carboplatin (TC) ChemotherapyDrug
Three-weekly induction chemotherapy regimen: Paclitaxel (135 mg/m², d1) + Carboplatin (AUC=5, d1), administered every 21 days.
Weekly TC ChemotherapyDrug
Paclitaxel (50 mg/m², intravenous infusion on Day 1 of each week) combined with Carboplatin (AUC 2, intravenous infusion on Day 1 of each week), administered for 5 consecutive weeks as part of concurrent chemoradiotherapy.
Four-Weekly TC Consolidation ChemotherapyDrug
Four-weekly consolidation chemotherapy regimen: Paclitaxel (175 mg/m², intravenous infusion on Day 1) combined with Carboplatin (AUC 5, intravenous infusion on Day 1), administered every 28 days for 2 cycles following concurrent chemoradiotherapy.
Definitive RadiotherapyRadiation
Definitive radiotherapy administered at a total dose of 50.4 Gy in 28 daily fractions (1.8 Gy per fraction) over approximately 5.5 weeks, delivered concurrently with weekly chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Induction group | Experimental | Patients receive induction therapy with sintilimab plus 3-weekly paclitaxel/carboplatin for 2 cycles, followed by concurrent chemoradiotherapy (weekly paclitaxel/carboplatin plus radiotherapy). Receives: Biological: Sintilimab; Drug: 3-Weekly Paclitaxel plus Carboplatin (TC) Chemotherapy; Drug: Weekly TC Chemotherapy; Radiation: Definitive Radiotherapy |
| Standard group | Active comparator | Patients receive concurrent chemoradiotherapy (weekly paclitaxel/carboplatin with radiotherapy), followed by 2 cycles of consolidation chemotherapy (4-weekly paclitaxel/carboplatin). Receives: Drug: Weekly TC Chemotherapy; Drug: Four-Weekly TC Consolidation Chemotherapy; Radiation: Definitive Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Measured: From the date of randomization to 3 years or until death, whichever comes first.
Secondary outcomes (3)
Progression-free survival
Measured: From the date of randomization to 3 years or until disease progression or death, whichever occurs first.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measured: For the duration of treatment plus 30 days after the last dose.
Objective response rate
Measured: One month after the completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Jun 2021
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Bethune Charitable Foundation
- Responsible party
- Principal investigator, Ye jinjun, Jiangsu Cancer Institute & Hospital
- Investigators
- Jinjun Ye, Principal investigator, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306663
- Sponsor's protocol ID
- ESO-Nanjing7
- Acronym
- ESO-Nanjing7
- Status last verified
- Dec 2025
- First submitted
- 14 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab Combined With Chemotherapy Induction Therapy Followed by Concurrent Chemoradiotherapy vs. Concurrent Chemoradiotherapy for Esophageal Cancer: A Randomized Controlled Phase Ⅲ Clinical Study
- ClinicalTrials.gov ID
- NCT07306663
- Acronym / sponsor ID
- ESO-Nanjing7 / ESO-Nanjing7
- Conditions
- Esophageal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Collaborators
- Beijing Bethune Charitable Foundation
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 29 Dec 2025 (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 objective of this clinical trial is to determine whether the addition of immunotherapy combined with chemotherapy before chemoradiotherapy can increase the survival rate of patients with esophageal cancer. It will also assess the safety of this regimen. The primary questions it aims to answer include:
- Can the addition of immunotherapy combined with chemotherapy before chemoradiotherapy reduce the rate of disease recurrence among participants?
- What adverse reactions will participants experience during the treatment process?
- Compared with traditional chemoradiotherapy, will this regimen extend the survival period of participants?
Participants will:
- Undergo two cycles of immunotherapy combined with chemotherapy, administered every three weeks, followed by concurrent chemoradiotherapy, which includes 28 sessions of radiotherapy and five sessions of chemotherapy during the concurrent period; or proceed directly to concurrent chemoradiotherapy, and then receive two cycles of chemotherapy after the completion of radiotherapy, administered once a month.
- Undergo regular tests and examinations to evaluate efficacy and safety.
- Record symptoms that occur during the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction group | Experimental | Biological: Sintilimab, Drug: 3-Weekly Paclitaxel plus Carboplatin (TC) Chemotherapy, Drug: Weekly TC Chemotherapy, Radiation: Definitive RadiotherapyPatients receive induction therapy with sintilimab plus 3-weekly paclitaxel/carboplatin for 2 cycles, followed by concurrent chemoradiotherapy (weekly paclitaxel/carboplatin plus radiotherapy). |
| Standard group | Active comparator | Drug: Weekly TC Chemotherapy, Drug: Four-Weekly TC Consolidation Chemotherapy, Radiation: Definitive RadiotherapyPatients receive concurrent chemoradiotherapy (weekly paclitaxel/carboplatin with radiotherapy), followed by 2 cycles of consolidation chemotherapy (4-weekly paclitaxel/carboplatin). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily participate and provide written informed consent;
- Age 18-75 years, regardless of gender;
- Histologically or cytologically confirmed esophageal squamous cell carcinoma;
- Patients with inoperable esophageal cancer;
- Clinical stage Ⅱ-ⅣA (AJCC 8th edition esophageal cancer staging system, including stage ⅣB with supraclavicular lymph node metastasis but excluding other distant metastatic stage ⅣB);
Key exclusion criteria (9 listed)
- Esophageal perforation or hematemesis;
- Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (patients with hypothyroidism stable on hormone replacement therapy for ≥4 weeks with TSH/FT4 within normal range may be included); additionally, patients who have used immunosuppressants within 28 days will be excluded, except for steroid use for managing chemoradiation-related toxicities;
- Previous or ongoing treatment with other types of PD-1 antibodies, or prior immunotherapy targeting PD-1/PD-L1;
- Known allergic reaction to macromolecular protein drugs or sintilimab or any of its formulation components;
- Uncontrolled cardiac disease or clinical symptoms, such as: a. heart failure of NYHA class II or above; b. unstable angina; c. myocardial infarction within the past year; d. supraventricular or ventricular arrhythmias requiring clinical intervention;
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 |
|---|---|---|
| Sintilimab200mg, once every three weeks, administered before concurrent chemoradiotherapy. | Biological | Induction group |
| 3-Weekly Paclitaxel plus Carboplatin (TC) ChemotherapyThree-weekly induction chemotherapy regimen: Paclitaxel (135 mg/m², d1) + Carboplatin (AUC=5, d1), administered every 21 days. | Drug | Induction group |
| Weekly TC ChemotherapyPaclitaxel (50 mg/m², intravenous infusion on Day 1 of each week) combined with Carboplatin (AUC 2, intravenous infusion on Day 1 of each week), administered for 5 consecutive weeks as part of concurrent chemoradiotherapy. | Drug | Induction group, Standard group |
| Four-Weekly TC Consolidation ChemotherapyFour-weekly consolidation chemotherapy regimen: Paclitaxel (175 mg/m², intravenous infusion on Day 1) combined with Carboplatin (AUC 5, intravenous infusion on Day 1), administered every 28 days for 2 cycles following concurrent chemoradiotherapy. | Drug | Standard group |
| Definitive RadiotherapyDefinitive radiotherapy administered at a total dose of 50.4 Gy in 28 daily fractions (1.8 Gy per fraction) over approximately 5.5 weeks, delivered concurrently with weekly chemotherapy. | Radiation | Induction group, Standard group |
Primary outcome
Overall survival rate
Time frame: From the date of randomization to 3 years or until death, whichever comes first.
3 secondary outcomes
Progression-free survival
Time frame: From the date of randomization to 3 years or until disease progression or death, whichever occurs first.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: For the duration of treatment plus 30 days after the last dose.
Objective response rate
Time frame: One month after the completion of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jinjun Ye principal investigator
Jiangsu Cancer Institute & Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sintilimab, 3-Weekly Paclitaxel plus Carboplatin (TC) Chemotherapy and Weekly TC Chemotherapy in people with Esophageal Cancer, run by Jiangsu Cancer Institute & 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 8 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: under way, not looking for participants, as of the sponsor's last update on 29 Dec 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall survival rate (time frame: From the date of randomization to 3 years or until death, whichever comes first.). 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 29 Dec 2025.