Esophageal CarcinomaPhase 1/2NCT05777707
Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Esophageal Carcinoma
A Phase 1/2 study testing PD-1 blockade, Albumin paclitaxel and Carboplatin/Nedaplatin in people with Esophageal Carcinoma and Neoadjuvant Immunotherapy, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This prospective study aims to clarify the clinical efficacy and survival prognosis of neoadjuvant immune checkpoint inhibitor (ICI) combined with chemotherapy for esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Esophageal Carcinoma, Neoadjuvant Immunotherapy
- What is being tested?
- PD-1 blockade, Albumin paclitaxel and Carboplatin/Nedaplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2020to 31 Dec 2024
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years and ≤89 years;
- pathological histological examination confirmed the diagnosis of esophageal squamous cell carcinoma and esophageal adenocarcinoma;
- clinical stage II-IVA;
- adequate organ function;
- no previous chemotherapy or radiotherapy;
- voluntarily signed informed consent.
Who cannot join
- the presence of concurrent malignancies that interfere with the prognosis of esophageal cancer;
- patients with immunodeficiency or autoimmune diseases that seriously affect the body's immune system, such as those who test positive for HIV;
- patients undergoing systemic corticosteroid or other immunosuppressive treatments;
- patients with a history of allergy to the components of this test drug.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qin li
Beijing, Beijing Municipality, 100029
Qin Li, MD, 13701288153, qinli128003@ccmu.edu.cn
About this study
Official title: Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Locally Advanced Esophageal Carcinoma
This prospective study aims to clarify the clinical efficacy and survival prognosis of neoadjuvant immune checkpoint inhibitor (ICI) combined with chemotherapy for esophageal cancer. It also explores predictive biomarkers and potential therapeutic targets for locally advanced esophageal cancer based on plasma metabolomics and peripheral blood immune cell clustering analysis. Each patient received 2-3 cycles of neoadjuvant immunotherapy with programmed cell death 1 (PD-1) blockade in combination with albumin paclitaxel and platinum. Exploratory analysis of plasma metabolomics combined with peripheral blood subsets of immune cells can reveal biomarkers that predict the efficacy and prognosis of patients undergoing neoadjuvant immunotherapy for locally advanced esophageal cancer, which also provide new ideas for the selection of immune adjuvants and therapeutic targets in ICIs combination therapy strategies.
- Conditions
- Esophageal Carcinoma, Neoadjuvant Immunotherapy
- Being tested
- PD-1 blockade, Albumin paclitaxel, Carboplatin/Nedaplatin
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 blockadeDrug
PD-1 blockade (Sintilimab/Camrelizumab/Toripalimab/Tislelizumab), 200 mg, IV., every 3 weeks, 2-3 cycles.
Albumin paclitaxelDrug
Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles.
Carboplatin/NedaplatinDrug
Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant PD-1 Blockade Plus Chemotherapy | Experimental | PD-1 blockade, 200 mg, IV., every 3 weeks, 2-3 cycles； Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles； Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles. Receives: Drug: PD-1 blockade; Drug: Albumin paclitaxel; Drug: Carboplatin/Nedaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Disease-free survival was defined as the time from randomization until the first documented disease recurrence or death due to any cause.
Measured: 24 months
Secondary outcomes (3)
Pathologic complete remission (PCR)
Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell.
Measured: 4 weeks after surgery
Major Pathologic Response (MPR)
MPR was defined as the presence of viable tumor cells≤10% in the resected tumor specimen.
Measured: 4 weeks after surgery
Overall survival (OS)
Overall survival was defined as the time from randomization grouping to the time of death due to any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start29 Oct 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CarcinomaStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777707
- Sponsor's protocol ID
- BeijingHF
- Status last verified
- Jan 2023
- First submitted
- 30 Jan 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Locally Advanced Esophageal Carcinoma
- ClinicalTrials.gov ID
- NCT05777707
- Acronym / sponsor ID
- BeijingHF
- Conditions
- Esophageal Carcinoma, Neoadjuvant Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Mar 2023 (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 prospective study aims to clarify the clinical efficacy and survival prognosis of neoadjuvant immune checkpoint inhibitor (ICI) combined with chemotherapy for esophageal cancer. It also explores predictive biomarkers and potential therapeutic targets for locally advanced esophageal cancer based on plasma metabolomics and peripheral blood immune cell clustering analysis. Each patient received 2-3 cycles of neoadjuvant immunotherapy with programmed cell death 1 (PD-1) blockade in combination with albumin paclitaxel and platinum. Exploratory analysis of plasma metabolomics combined with peripheral blood subsets of immune cells can reveal biomarkers that predict the efficacy and prognosis of patients undergoing neoadjuvant immunotherapy for locally advanced esophageal cancer, which also provide new ideas for the selection of immune adjuvants and therapeutic targets in ICIs combination therapy strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant PD-1 Blockade Plus Chemotherapy | Experimental | Drug: PD-1 blockade, Drug: Albumin paclitaxel, Drug: Carboplatin/NedaplatinPD-1 blockade, 200 mg, IV., every 3 weeks, 2-3 cycles； Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles； Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥ 18 years and ≤89 years;
- pathological histological examination confirmed the diagnosis of esophageal squamous cell carcinoma and esophageal adenocarcinoma;
- clinical stage II-IVA;
- adequate organ function;
- no previous chemotherapy or radiotherapy;
Key exclusion criteria (4 listed)
- the presence of concurrent malignancies that interfere with the prognosis of esophageal cancer;
- patients with immunodeficiency or autoimmune diseases that seriously affect the body's immune system, such as those who test positive for HIV;
- patients undergoing systemic corticosteroid or other immunosuppressive treatments;
- patients with a history of allergy to the components of this test drug.
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 |
|---|---|---|
| PD-1 blockadePD-1 blockade (Sintilimab/Camrelizumab/Toripalimab/Tislelizumab), 200 mg, IV., every 3 weeks, 2-3 cycles. | Drug | Neoadjuvant PD-1 Blockade Plus Chemotherapy |
| Albumin paclitaxelAlbumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles. | Drug | Neoadjuvant PD-1 Blockade Plus Chemotherapy |
| Carboplatin/NedaplatinCarboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles. | Drug | Neoadjuvant PD-1 Blockade Plus Chemotherapy |
Primary outcome
Disease-free survival (DFS)
Time frame: 24 months
Disease-free survival was defined as the time from randomization until the first documented disease recurrence or death due to any cause.
3 secondary outcomes
Pathologic complete remission (PCR)
Time frame: 4 weeks after surgery
Major Pathologic Response (MPR)
Time frame: 4 weeks after surgery
Overall survival (OS)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
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 PD-1 blockade, Albumin paclitaxel and Carboplatin/Nedaplatin in people with Esophageal Carcinoma and Neoadjuvant Immunotherapy, run by Beijing Friendship 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 4 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 21 Mar 2023. 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?
Contact Qin Li, MD (13701288153, qinli128003@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 24 months). 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 21 Mar 2023.