Immunotherapy;Envafolimab; Esophageal CancerPhase 2NCT05828381
Envafolimab Combined With Abraxane and Cisplatinas as Neoadjuvant Treatment for Resectable Esophageal Cancer
A Phase 2 study testing Envafolimab, Abraxane and Cisplatin in people with Immunotherapy;Envafolimab; Esophageal Cancer, run by Fujian Medical University Union Hospital.
Trial summary
Big breakthroughs have been made in the combination therapy of immune checkpoint inhibitors when it comes to the neoadjuvant therapy of esophageal cancer. Several studies, such as Cross, have shown that although preoperative adjuvant chemoradiotherapy could improve the local control rate of lesions, the incidence of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immunotherapy;Envafolimab; Esophageal Cancer
- What is being tested?
- Envafolimab, Abraxane and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Dec 2025
- Phase
- Phase 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
- The subject voluntarily joins this study and is able to sign the informed consent form with good compliance;
- 18-75 years of age (at the time of signing the informed consent);
- ECOG score 0-1;
- Expected survival ≥ 12 weeks;
- Patients with confirmed diagnosis of esophageal squamous cell carcinoma by histopathologic examination of primary tumor biopsy, who are definitely diagnosed with clinical stage of esophageal cancer by CT or MRI or color Doppler ultrasound or PET-CT or endoscopic ultrasonography T1-3N1-3M0 or T3N0M0 (AJCC 8 th) and are suitable for treatment with this study protocol as assessed by the investigator.
- No previous anti-tumor therapy, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc . However, exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgical procedures performed to confirm the diagnosis, staging, and surgical treatment of esophageal cancer are acceptable.
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- Adequate major organ function meeting the following criteria:1) Hematology (without blood transfusion or hematopoietic stimulating factor drugs within 14 days): hemoglobin (Hb) ≥ 90 g/L; absolute neutrophil count (ANC) ≥ 1.5 × 10 9/L; platelet (PLT) ≥ 100 × 10 9/L;Biochemistry: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; serum total bilirubin (TBIL) ≤ 1.5 × ULN (in subjects with Gilbert 's syndrome, ≤ 3 × ULN); serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min;3)Urine routine: urine protein < 2 +; if urine protein ≥ 2 +, 24-hour urine protein quantification must show protein ≤ 1 g;4) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN;5) Euthyroid defined as thyroid stimulating hormone (TSH) within normal limits. If baseline TSH is out of normal range, subjects with total T3 (or FT3) and FT4 within normal range can also be enrolled;
- Adequate organ function as judged clinically by the physician ;
- Subjects of childbearing potential must use adequate contraception during this study and for 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating.
Who cannot join
- Suffered from other malignant tumors within 5 years before the start of treatment in this study;
- Patients with tumor invasion of cervical esophagus or upper thoracic segment requiring laryngectomy;
- Patients with high risk of bleeding or perforation due to tumor obvious invasion of the organs adjacent to the esophageal lesion (major artery or trachea) or patients with fistula;
- Subjects with any severe or uncontrolled medical conditions;
- Poor blood pressure control (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
- Patients with poorly controlled cardiac clinical symptoms or diseases such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
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- The subject had an active infection or unexplained fever during screening and prior to initial administration (if the subject had fever due to the tumor, as determined by the investigator, he could be enrolled);
- Previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.;
- Patients with acute or chronic active Hepatitis B ;
- A history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
- Poor diabetes control;
- Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;
- Study participants who received major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the start of treatment or a wound or fracture that has not healed for a long time;
- Severe arteriovenous thrombosis events;
- Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders;
- Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;
- Subjects with known central nervous system metastatic and/or cancerous meningitis;
- Study the history of live attenuated vaccine vaccination within 14 days prior to the start of treatment or planned live attenuated vaccine vaccination during the study period;
- Active autoimmune diseases requiring systemic treatment have occurred within 2 years prior to the initiation of the study treatment, other than alternative therapies;
- Diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy;
- People with a history of active tuberculosis;
- Participating in or having participated in other clinical investigators within 4 weeks prior to study initiation;
- Previous treatment with other PD-1/PD-L1 inhibitors could not be included in the group; the subject known to have a prior allergy to macromolecular protein preparations;
- Those who are known to be allergic to the active ingredients or excipients of the drug in this study, such as Envollizumab, albumin paclitaxel and cisplatin;
- Subjects who, in the investigator's judgment, have a concomitant medical condition that seriously endangers subjects' safety or interferes with the completion of the study, or who are deemed unsuitable for enrollment for other reasons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Single-arm Multicenter Clinical Trial of Envafolimab Combined With Abraxane and Cisplatinas in Resectable Esophageal Squamous Cell Cancer
Big breakthroughs have been made in the combination therapy of immune checkpoint inhibitors when it comes to the neoadjuvant therapy of esophageal cancer. Several studies, such as Cross, have shown that although preoperative adjuvant chemoradiotherapy could improve the local control rate of lesions, the incidence of distant metastasis still remains high in the long term. Compared with preoperative adjuvant chemoradiotherapy, the treatment of combination with immunotherapy has shown a lot of advantages such as shorter hospital stay, fewer complications and lower cost, which may replace preoperative chemotherapy or chemoradiotherapy for esophageal cancer as a new treatment .This is a single-arm, exploratory phase II clinical study to evaluate the efficacy and safety of Envafolimab combination with Abraxane and cisplatin as preoperative neoadjuvant therapy for patients with resectable esophageal squamous cell carcer. In the study, all subjects meeting enrollment criteria will receive 2 cycles of neoadjuvant therapy with Envafolimab combined with Abraxane and cisplatin as scheduled. Around 4-6 weeks after the last neoadjuvant therapy, they will receive radical surgery. Evaluation will be conducted after the completion of the surgical cycle to determine the pathological complete response rate , R0 resection rate and major pathological response rate of these treated patients.
The objective is To evaluate the efficacy and safety of Enbrelizumab in combination with Abraxane and cisplatin for preoperative neoadjuvant therapy in patients with resectable esophageal squamous cancer.
- Being tested
- Envafolimab, Abraxane, Cisplatin
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvafolimabDrug
300mg,sc,d1,q3w; for a total of 2 cycles.
AbraxaneDrug
100mg/m2,ivgtt, D1、D8,q3w ,for a total of 2 cycles
CisplatinDrug
75 mg/m2 vigtt D1 , q3w , for a total of 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab combination with Abraxane and cisplatin | Experimental | Arm description：Envafolimab:300mg,sc,d1,q3w; for a total of 2 cycles. Chemotherapy： Abraxane + Cisplatin Abraxane :100mg/m2,ivgtt, D1、D8,q3w ,for a total of 2 cycles. Cisplatin : 75 mg/m 2 vigtt D1 , q3w , for a total of 2 cycles. Receives: Drug: Envafolimab; Drug: Abraxane; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pathological complete response rate
Measured: 1 year
Secondary outcomes (3)
The R0 resection rate
Measured: 1 year
The major pathological response rate
Measured: 1 year
The disease free survival rate
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 posted25 Apr 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunotherapy;Envafolimab; Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828381
- Sponsor's protocol ID
- Mingqiang Kang
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Multicenter Clinical Trial of Envafolimab Combined With Abraxane and Cisplatinas in Resectable Esophageal Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT05828381
- Acronym / sponsor ID
- Mingqiang Kang
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 25 Apr 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.
Big breakthroughs have been made in the combination therapy of immune checkpoint inhibitors when it comes to the neoadjuvant therapy of esophageal cancer. Several studies, such as Cross, have shown that although preoperative adjuvant chemoradiotherapy could improve the local control rate of lesions, the incidence of distant metastasis still remains high in the long term. Compared with preoperative adjuvant chemoradiotherapy, the treatment of combination with immunotherapy has shown a lot of advantages such as shorter hospital stay, fewer complications and lower cost, which may replace preoperative chemotherapy or chemoradiotherapy for esophageal cancer as a new treatment .This is a single-arm, exploratory phase II clinical study to evaluate the efficacy and safety of Envafolimab combination with Abraxane and cisplatin as preoperative neoadjuvant therapy for patients with resectable esophageal squamous cell carcer. In the study, all subjects meeting enrollment criteria will receive 2 cycles of neoadjuvant therapy with Envafolimab combined with Abraxane and cisplatin as scheduled. Around 4-6 weeks after the last neoadjuvant therapy, they will receive radical surgery. Evaluation will be conducted after the completion of the surgical cycle to determine the pathological complete response rate , R0 resection rate and major pathological response rate of these treated patients.
The objective is To evaluate the efficacy and safety of Enbrelizumab in combination with Abraxane and cisplatin for preoperative neoadjuvant therapy in patients with resectable esophageal squamous cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Envafolimab combination with Abraxane and cisplatin | Experimental | Drug: Envafolimab, Drug: Abraxane, Drug: CisplatinArm description：Envafolimab:300mg,sc,d1,q3w; for a total of 2 cycles. Chemotherapy： Abraxane + Cisplatin Abraxane :100mg/m2,ivgtt, D1、D8,q3w ,for a total of 2 cycles. Cisplatin : 75 mg/m 2 vigtt D1 , q3w , for a total of 2 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject voluntarily joins this study and is able to sign the informed consent form with good compliance;
- 18-75 years of age (at the time of signing the informed consent);
- ECOG score 0-1;
- Expected survival ≥ 12 weeks;
- Patients with confirmed diagnosis of esophageal squamous cell carcinoma by histopathologic examination of primary tumor biopsy, who are definitely diagnosed with clinical stage of esophageal cancer by CT or MRI or color Doppler ultrasound or PET-CT or endoscopic ultrasonography T1-3N1-3M0 or T3N0M0 (AJCC 8 th) and are suitable for treatment with this study protocol as assessed by the investigator.
Key exclusion criteria (25 listed)
- Suffered from other malignant tumors within 5 years before the start of treatment in this study;
- Patients with tumor invasion of cervical esophagus or upper thoracic segment requiring laryngectomy;
- Patients with high risk of bleeding or perforation due to tumor obvious invasion of the organs adjacent to the esophageal lesion (major artery or trachea) or patients with fistula;
- Subjects with any severe or uncontrolled medical conditions;
- Poor blood pressure control (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
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 |
|---|---|---|
| Envafolimab300mg,sc,d1,q3w; for a total of 2 cycles. | Drug | Envafolimab combination with Abraxane and cisplatin |
| Abraxane100mg/m2,ivgtt, D1、D8,q3w ,for a total of 2 cycles | Drug | Envafolimab combination with Abraxane and cisplatin |
| Cisplatin75 mg/m2 vigtt D1 , q3w , for a total of 2 cycles | Drug | Envafolimab combination with Abraxane and cisplatin |
Primary outcome
The pathological complete response rate
Time frame: 1 year
3 secondary outcomes
The R0 resection rate
Time frame: 1 year
The major pathological response rate
Time frame: 1 year
The disease free survival rate
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 25 Apr 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envafolimab, Abraxane and Cisplatin in people with Immunotherapy;Envafolimab; Esophageal Cancer, run by Fujian Medical University Union Hospital.
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 9 inclusion and 25 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 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingqiang Kang (13365910323, yufjfz@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pathological complete response rate (time frame: 1 year). 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 25 Apr 2023.