Esophageal Squamous Cell CarcinomaPhase 2NCT04666090
Carrelizumab, Chemotherapy and Apatinib in the Neoadjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Carillizumab, Esophagectomy and Samples in people with Esophageal Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy
- What is being tested?
- Carillizumab, Esophagectomy and Samples
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2020to Nov 2030
- Phase
- Phase 2
- 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
- signed informed consent;
- patients age 18 to 75 years old
- primary resectable, histologically confirmed esophageal squamous cell cancer;
- Esophageal squamous cell carcinoma the clinical stage was IIA-IVA (according to AJCC TNM stage, 8th edition).
- ECOG PS 0-1.
- No distant metastasis, the diseases could be resectable assessed by thoracic oncologist;
Who cannot join
- with significant cardiovascular disease;
- current treatment with anti-viral therapy or HBV;
- Female patients who are pregnant or lactating;
- history of malignancy within 5 years prior to screening;
- active or history of autoimmune disease or immune deficiency;
- signs of distant metastases.
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China, 310009
About this study
Official title: A Prospective, One-arm, Single-center, Phase Ⅱ Clinical Study of Carrelizumab Combined With Chemotherapy and Antiangiogenic Drugs in the Neoadjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma
China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased.
For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients.
Read more
According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of esophageal cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that Carrillizumab provided higher overall response rate for advanced esophageal cancer.
However, in patients with locally advanced esophageal cancer, the efficacy of Carrillizumab combined with chemotherapy and apatinib for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of Carrillizumab combined with chemotherapy and antiangiogenic drugs in the neoadjuvant therapy of resectable esophageal squamous cell carcinoma.
Read the detailed description
Esophageal cancer is a common malignant tumor of the digestive tract. Every year, there are about 400,000 new cases of esophageal cancer in the world and about 300,000 people dying of this disease. China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased. Early local invasion, lymph node metastasis and distant metastasis are the main causes of poor prognosis for the patients with esophageal squamous cell carcinoma.
For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients.
In recent years, PD-1 antibody is undoubtedly the most dazzling star in the field of tumor therapy. It shows excellent efficacy in of the different kind of tumors. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4% (Meta-analysis of 1350 Chinese and Japanese subjects showed that the over-expression of PD-L1 tended to decrease overall survival). Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of esophageal cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that Carrillizumab provided higher overall response rate for advanced esophageal cancer. It also provided superior progression free survival and overall survival compared with Pembrolizuma and paclitaxel. 2020 Chinese Society Of Clinical Oncology esophagus cancer guidelines recommended Carrillizumab as the first level for squamous cell carcinomas.
However, in patients with locally advanced esophageal cancer, the efficacy of Carrillizumab combined with chemotherapy and apatinib for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of Carrillizumab combined with chemotherapy and antiangiogenic drugs in the neoadjuvant therapy of resectable esophageal squamous cell carcinoma.
- Being tested
- Carillizumab, Esophagectomy, Samples
- Keywords
- Carrelizumab, Neoadjuvant Treatment, Esophageal Squamous Cell Carcinoma, Apatinib
- 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.
CarillizumabDrug
Also called Esophagectomy, Collecting samples from participant
administration regimen: Carillizumab 200mg, IV, D1; Albumin paclitaxel 150mg/m2, D1; Nedaplatin 50 mg/m2, D1; Apatinib 250mg Po D2-4. Preoperative neoadjuvant therapy for 2-3 cycles, one cycle every 14 days.
EsophagectomyProcedure or surgery
Laparoscopy combined with thoracoscope radical resection of esophageal carcinoma
SamplesOther
Blood, Tumour and Saliva will be Collected from participant. Fate of sample is Destruction after use
| Study group | Role | What they receive |
|---|---|---|
| Carillizumab | Experimental | Preoperative neoadjuvant therapy for 2-3 cycles. Radical surgery is performed 4-6 weeks after the last dose. Postoperative radiotherapy is determined according to the clinical situation and pathological stage of the patient.
Carillizumab can be maintained for a maximum of 1 year. During the study, patients were be followed until disease progression, withdrawal of informed consent, loss of follow-up, or death. Receives: Drug: Carillizumab; Procedure: Esophagectomy; Other: Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (PCR)
No residual invasive tumor cells were found in the pathological examination of resected specimens.
Measured: 1 month after surgery
Secondary outcomes (7)
Major Pathological Response (MPR)
In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.
Measured: 1 month after surgery
Objective Response Rate (ORR)
The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria
Measured: 1 month after surgery
2-year and 5-year overall survival
The proportion of all study cases in which no death from any cause occurred within 2 years and 5 years after surgery
Measured: 2-year and 5-year after surgery
2-year and 5-year disease-free survival
No recurrence, distant metastasis, or death within 2 years and 5 years after surgery accounted for the proportion of all cases studied.
Measured: 2-year and 5-year after surgery
Incidence of Treatment-related Adverse Events
Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0
Measured: 1 month after surgery
R0 resection rate
The pathological results showed that the incision margin was negative and no residual cancer cells were found under the microscope
Measured: 1 month after surgery
The changes in the peripheral blood immunoprofile among non-PCR (NPCR) and PCR patients
By using mass spectrometry (CyTOF) and bioinformatics pipelines, we comprehensively characterized the immune landscape in the peripheral blood of ESCC patients before and after anti-PD-1 immunotherapy, aiming to explore the immune subsets correlated with neoadjuvant immunotherapy response
Measured: 3 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start23 Nov 2020
- Primary completion31 Dec 2022
- Study completionNov 2030 (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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weilin Wang, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666090
- Sponsor's protocol ID
- 2020-795
- Status last verified
- Sep 2026
- First submitted
- 3 Dec 2020
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu Z, Wu C, Zhao J, Wu C, Peng H, Wang Q, Bai R, Fang X, He H, Shen H, Wu M. Camrelizumab, chemotherapy and apatinib in the neoadjuvant treatment of resectable oesophageal squamous cell carcinoma: a single-arm phase 2 trial. EClinicalMedicine. 2024 Apr 6;71:102579. doi: 10.1016/j.eclinm.2024.102579. eCollection 2024 May.
PubMed 38618203
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, One-arm, Single-center, Phase Ⅱ Clinical Study of Carrelizumab Combined With Chemotherapy and Antiangiogenic Drugs in the Neoadjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04666090
- Acronym / sponsor ID
- 2020-795
- Keywords
- Carrelizumab, Neoadjuvant Treatment, Esophageal Squamous Cell Carcinoma, Apatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- Nov 2030 (estimated)
- First posted
- 14 Dec 2020 (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.
China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased.
For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients.
According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of esophageal cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that Carrillizumab provided higher overall response rate for advanced esophageal cancer.
However, in patients with locally advanced esophageal cancer, the efficacy of Carrillizumab combined with chemotherapy and apatinib for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of Carrillizumab combined with chemotherapy and antiangiogenic drugs in the neoadjuvant therapy of resectable esophageal squamous cell carcinoma.
Detailed description
Esophageal cancer is a common malignant tumor of the digestive tract. Every year, there are about 400,000 new cases of esophageal cancer in the world and about 300,000 people dying of this disease. China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased. Early local invasion, lymph node metastasis and distant metastasis are the main causes of poor prognosis for the patients with esophageal squamous cell carcinoma.
For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients.
In recent years, PD-1 antibody is undoubtedly the most dazzling star in the field of tumor therapy. It shows excellent efficacy in of the different kind of tumors. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4% (Meta-analysis of 1350 Chinese and Japanese subjects showed that the over-expression of PD-L1 tended to decrease overall survival). Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of esophageal cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that Carrillizumab provided higher overall response rate for advanced esophageal cancer. It also provided superior progression free survival and overall survival compared with Pembrolizuma and paclitaxel. 2020 Chinese Society Of Clinical Oncology esophagus cancer guidelines recommended Carrillizumab as the first level for squamous cell carcinomas.
However, in patients with locally advanced esophageal cancer, the efficacy of Carrillizumab combined with chemotherapy and apatinib for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of Carrillizumab combined with chemotherapy and antiangiogenic drugs in the neoadjuvant therapy of resectable esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carillizumab | Experimental | Drug: Carillizumab, Procedure: Esophagectomy, Other: SamplesPreoperative neoadjuvant therapy for 2-3 cycles. Radical surgery is performed 4-6 weeks after the last dose. Postoperative radiotherapy is determined according to the clinical situation and pathological stage of the patient. Carillizumab can be maintained for a maximum of 1 year. During the study, patients were be followed until disease progression, withdrawal of informed consent, loss of follow-up, or death. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- signed informed consent;
- patients age 18 to 75 years old
- primary resectable, histologically confirmed esophageal squamous cell cancer;
- Esophageal squamous cell carcinoma the clinical stage was IIA-IVA (according to AJCC TNM stage, 8th edition).
- ECOG PS 0-1.
Key exclusion criteria (6 listed)
- with significant cardiovascular disease;
- current treatment with anti-viral therapy or HBV;
- Female patients who are pregnant or lactating;
- history of malignancy within 5 years prior to screening;
- active or history of autoimmune disease or immune deficiency;
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 |
|---|---|---|
| CarillizumabAlso: Esophagectomy, Collecting samples from participantadministration regimen: Carillizumab 200mg, IV, D1; Albumin paclitaxel 150mg/m2, D1; Nedaplatin 50 mg/m2, D1; Apatinib 250mg Po D2-4. Preoperative neoadjuvant therapy for 2-3 cycles, one cycle every 14 days. | Drug | Carillizumab |
| EsophagectomyLaparoscopy combined with thoracoscope radical resection of esophageal carcinoma | Procedure or surgery | Carillizumab |
| SamplesBlood, Tumour and Saliva will be Collected from participant. Fate of sample is Destruction after use | Other | Carillizumab |
Primary outcome
Pathological Complete Response (PCR)
Time frame: 1 month after surgery
No residual invasive tumor cells were found in the pathological examination of resected specimens.
7 secondary outcomes
Major Pathological Response (MPR)
Time frame: 1 month after surgery
Objective Response Rate (ORR)
Time frame: 1 month after surgery
2-year and 5-year overall survival
Time frame: 2-year and 5-year after surgery
2-year and 5-year disease-free survival
Time frame: 2-year and 5-year after surgery
Incidence of Treatment-related Adverse Events
Time frame: 1 month after surgery
R0 resection rate
Time frame: 1 month after surgery
The changes in the peripheral blood immunoprofile among non-PCR (NPCR) and PCR patients
Time frame: 3 month after surgery
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 2 Oct 2026.
- Derived from this study: PubMed 38618203Wu Z, Wu C, Zhao J, Wu C, Peng H, Wang Q, Bai R, Fang X, He H, Shen H, Wu M. Camrelizumab, chemotherapy and apatinib in the neoadjuvant treatment of resectable oesophageal squamous cell carcinoma: a single-arm phase 2 trial. EClinicalMedicine. 2024 Apr 6;71:102579. doi: 10.1016/j.eclinm.2024.102579. eCollection 2024 May.
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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.
Weilin Wang study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University
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 Carillizumab, Esophagectomy and Samples in people with Esophageal Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 inclusion and 6 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 2 Oct 2026. 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?
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?
Pathological Complete Response (PCR) (time frame: 1 month after surgery). 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 NCT04666090, 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 2 Oct 2026.