Esophageal Squamous Cell CarcinomaPhase 1/2NCT04506138
Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma
A Phase 1/2 study testing Camrelizumab, Paclitaxel for Injection (Albumin Bound) and Carboplatin in people with Esophageal Squamous Cell Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This study aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma 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?
- Camrelizumab, Paclitaxel for Injection (Albumin Bound) and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2020to 31 Dec 2025
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of thoracic Esophageal squamous cell carcinoma
- ECOG performance status 0-1
- Age 18-75 years
- Resectable disease, cT2-4aNanyM0 or cT1-3N+M0
- Life expectancy more than 6 months
- Use of an effective contraceptive for adults to prevent pregnancy
Who cannot join
- Not suitable for surgery
- Prior chemotherapy, radiotherapy and immune-oncology therapies for ESCC
- Prior esophageal, gastric, or gastro-esophageal junction surgery
- Esophageal ulcer, esophageal perforation，chest pain（≥middle level）
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Camrelizumab, Paclitaxel for Injection (Albumin Bound), Carboplatin
- 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.
CamrelizumabDrug
Camrelizumab 200mg D1, D22
Paclitaxel for Injection (Albumin Bound)Drug
Paclitaxel for Injection (Albumin Bound) 100mg/m^2 D1, D8, D22, D29
CarboplatinDrug
Carboplatin AUC5 D1, D22
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab plus Chemotherapy | Experimental | Not described Receives: Drug: Camrelizumab; Drug: Paclitaxel for Injection (Albumin Bound); Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete remission (PCR)
Measured: 12 weeks
Major Pathologic Response (MPR)
Measured: 12 weeks
Secondary outcomes (2)
Overall Survival (OS)
Measured: 5 years
Event Free Survival（EFS）
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start11 Aug 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chenqixun, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506138
- Sponsor's protocol ID
- ZJCH-2020183-II-ESCC
- Status last verified
- Dec 2021
- First submitted
- 5 Aug 2020
- Last updated
- 14 Dec 2021
- 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 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04506138
- Acronym / sponsor ID
- ZJCH-2020183-II-ESCC
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Aug 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.
This study aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for resectable thoracic 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 |
|---|---|---|
| Camrelizumab plus Chemotherapy | Experimental | Drug: Camrelizumab, Drug: Paclitaxel for Injection (Albumin Bound), Drug: Carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological diagnosis of thoracic Esophageal squamous cell carcinoma
- ECOG performance status 0-1
- Age 18-75 years
- Resectable disease, cT2-4aNanyM0 or cT1-3N+M0
- Life expectancy more than 6 months
Key exclusion criteria (5 listed)
- Not suitable for surgery
- Prior chemotherapy, radiotherapy and immune-oncology therapies for ESCC
- Prior esophageal, gastric, or gastro-esophageal junction surgery
- Esophageal ulcer, esophageal perforation，chest pain（≥middle level）
- Pregnant or lactating women
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 |
|---|---|---|
| CamrelizumabCamrelizumab 200mg D1, D22 | Drug | Camrelizumab plus Chemotherapy |
| Paclitaxel for Injection (Albumin Bound)Paclitaxel for Injection (Albumin Bound) 100mg/m^2 D1, D8, D22, D29 | Drug | Camrelizumab plus Chemotherapy |
| CarboplatinCarboplatin AUC5 D1, D22 | Drug | Camrelizumab plus Chemotherapy |
Primary outcome
Pathologic complete remission (PCR)
Time frame: 12 weeks
Major Pathologic Response (MPR)
Time frame: 12 weeks
2 secondary outcomes
Overall Survival (OS)
Time frame: 5 years
Event Free Survival（EFS）
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Camrelizumab, Paclitaxel for Injection (Albumin Bound) and Carboplatin 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 6 inclusion and 5 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 14 Dec 2021. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Pathologic complete remission (PCR) (time frame: 12 weeks). 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?
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 14 Dec 2021.