The Efficacy and Safety of Therapy Efficacy for Locally Advanced ESCCPhase 2NCT05947201
Neoadjuvant Treatment of Cadonilimab Combined Albumin-paclitaxel, Cisplatin and Fluorouracil for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Cadonilimab Combined Albumin-paclitaxel, Cisplatin and Fluorouracil in people with The Efficacy and Safety of Therapy Efficacy for Locally Advanced ESCC, run by Weijia Fang, MD at 1 site in China.
Trial summary
This is a single-arm clinical study to evaluate the efficacy and safety of Cadonilimab in combination with preoperative chemotherapy for locally advanced esophageal squamous cell carcinoma Locally Advanced Esophageal Squamous Cell Carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- The Efficacy and Safety of Therapy Efficacy for Locally Advanced ESCC
- What is being tested?
- Cadonilimab Combined Albumin-paclitaxel, Cisplatin and Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2023to 1 Oct 2024
- 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
- Participants who have given their consent and signed an informed consent form, are willing and able to comply with the study visits, treatment, laboratory tests, and other trial procedures.
- Patients with a pathological diagnosis of (thoracic) esophageal squamous cell carcinoma.
- Age between 18 and 75 years (inclusive), both male and female.
- Locally advanced esophageal squamous cell carcinoma without suspicious cervical lymph node metastasis and distant metastasis (cT1N1-3M0 or cT2-3N0-3M0, AJCC 8th edition).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- No prior systemic treatment for esophageal cancer (including chemotherapy, targeted therapy, immune checkpoint inhibitors such as anti-PD-1 or PD-L1 antibodies, anti-CTLA-4 antibodies, etc.).
Show all 14Show fewer
- Planned surgical treatment after completion of neoadjuvant therapy.
- Expected survival time of at least 6 months.
- Clearly measurable lesions that meet the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Adequate organ function based on laboratory values obtained during the screening period, including:
- 1) Hematology: no blood transfusions or blood products within 14 days, no use of G-CSF or other hematopoietic growth factors for correction, white blood cell count (WBC) ≥ 3.0 × 109/L, absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 75 × 109/L, hemoglobin (Hgb) ≥ 9 g/dL.
- 2) Blood chemistry: serum total bilirubin ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase or alanine aminotransferase ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis), serum creatinine ≤ 1.5 × ULN.
- 3) Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN.
- 4) Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%. 11. Female participants of childbearing potential must have a negative serum pregnancy test within 3 days before starting study drug and agree to use a medically accepted highly effective method of contraception (such as an intrauterine device, contraceptive pills, or condoms) during the study period and within 3 months after the last dose of study drug. Male participants with partners of childbearing potential must have undergone surgical sterilization or agree to use an effective method of contraception during the study period and within 3 months after the last dose of study drug.
Who cannot join
- History of or concurrent active malignancy other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer or other malignancy with no evidence of disease for at least 5 years.
- Active bleeding within 3 months; a history of arterial or venous thrombotic events within 6 months, such as stroke (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism; known inherited or acquired bleeding diathesis (e.g., coagulation factor deficiencies) or thrombotic disorders, such as patients with hemophilia; current or recent (within 10 days before the start of the study treatment) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes (allowed prophylactic use of low-dose aspirin and low-molecular-weight heparin); major surgery (excluding biopsy) within 4 weeks before starting study drug treatment or the surgical incision has not fully healed; current or recent (within 10 days before the start of the study treatment) use of aspirin (> 325 mg/day [maximum antiplatelet dose]) or other nonsteroidal anti-inflammatory drugs, dual antiplatelet therapy, clopidogrel, prasugrel, ticagrelor, or cilostazol.
- The patient has received systemic treatment, surgery, or radiotherapy for esophageal cancer, including immunotherapy such as anti-PD-1 or PD-L1 antibodies, anti-CTLA-4 antibodies, targeted therapy, or chemotherapy.
- The patient has used systemic corticosteroids or other systemic immunosuppressive drugs within 2 weeks before treatment, or is expected to use systemic immunosuppressive drugs during the trial. The use of inhaled glucocorticoids or physiological replacement doses of glucocorticoids is allowed.
- The patient has active autoimmune diseases. Patients with type 1 diabetes, hypothyroidism requiring replacement therapy only, skin diseases (such as vitiligo, psoriasis, or alopecia) that do not require systemic treatment or are not expected to recur without external triggering factors can be included in the trial.
- The patient has known active tuberculosis, is receiving anti-tuberculosis treatment, or has received anti-tuberculosis treatment within 1 year prior to the first dose.
Show all 15Show fewer
- The patient has severe, uncontrolled systemic diseases, such as refractory hypertension, severe active infection, etc.
- The patient has known human immunodeficiency virus (HIV) infection or is known to be HIV-seropositive.
- Untreated chronic hepatitis B or active carriers of hepatitis B virus (HBV) (HBV DNA >500 IU/mL) or active carriers of HCV detectable by HCV RNA. Note: Inactive carriers of hepatitis B surface antigen (HBsAg) or stable patients with treated chronic hepatitis B (HBV DNA < 500 IU/mL) can be included in the study.
- History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, or symptomatic interstitial lung disease, or active pneumonia detected by chest CT scan within 4 weeks prior to initial drug treatment in the study.
- Known symptomatic, untreated, or progressively advancing central nervous system (CNS) or leptomeningeal metastases.
- Known allergy to any investigational drug or excipient.
- Participation in other drug clinical trials within 4 weeks before enrollment.
- Breastfeeding women.
- As judged by the investigator, the patient has other factors that may affect the study results or may cause premature termination of the study, such as alcoholism, drug abuse, other serious illnesses (including mental illness) requiring concomitant treatment, significant laboratory abnormalities, or family or social factors that may affect the patient's safety.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lulu Liu
Hanzhou, Zhejiang, 0571
Lu lu Liu, M.D., 0571-87237587, liululu2001@zju.edu.cn
About this study
Official title: Neoadjuvant Treatment of Cadonilimab Combined Albumin-paclitaxel, Cisplatin and Fluorouracil for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma：A Single-Arm Phase 2 Clinical Trial
This is a single-arm clinical study to evaluate the efficacy and safety of Cadonilimab in combination with preoperative chemotherapy for locally advanced esophageal squamous cell carcinoma Locally Advanced Esophageal Squamous Cell Carcinoma
Read the detailed description
Esophageal cancer is the eighth most lethal tumor and the sixth leading cause of cancer-related deaths worldwide. Esophageal squamous cell carcinoma accounts for up to 95% of the pathological types and threatens the health of chinese residents. Investigator designed a single-arm, open-label, phase II trial and the purpose of this study is to observe and evaluate the efficacy and safety of Cadonilimab combined with preoperative chemotherapy for locally advanced esophageal squamous cell carcinoma.
- Being tested
- Cadonilimab Combined Albumin-paclitaxel, Cisplatin and Fluorouracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadonilimab Combined Albumin-paclitaxel, Cisplatin and FluorouracilDrug
Also called rutine
If the addition of Cadonilimab to neoadjuvant chemotherapy further improve the efficiency for locally advanced esophageal squamous cell carcinoma
| Study group | Role | What they receive |
|---|---|---|
| AK104+cisplatin+albumin paclitaxel+fluorouracil | Experimental | AK104 (10 mg/kg d1), in combination with cisplatin (20 mg/m2 on d1-3) and albumin paclitaxel (100mg/m2 on d1,d8), fluorouracil (600 mg/m2 on d1-5) Q3W, intravenously Receives: Drug: Cadonilimab Combined Albumin-paclitaxel, Cisplatin and Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response (pCR) of the patients' resected tumors
PCR is defined as pT0N0M0
Measured: 1 month after resection
Secondary outcomes (5)
Major pathologic response (MPR)
MPR is defined as viable tumor comprised ≤ 10% of resected tumor specimens.
Measured: 1 month after resection
Disease Free Survival (DFS)
Percentage of Participants With DFS, as Assessed by RECIST 1.1. DFS is defined as the time from randomization to the first documented disease progression of local recurrence or distant metastasis or death due to any cause.
Measured: 3 and 5 years
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: 3 and 5 years
pathological downstaging rate
The rate of patients with reduced pathological stage after neoadjuvant therapy
Measured: 1 month after resection
R0 resection rate
The rate of patients with R0 resection after neoadjuvant therapy
Measured: 1 month after resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start8 May 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Efficacy and Safety of Therapy Efficacy for Locally Advanced ESCCStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients fulfilling Eligibility Criteria will be included in our study. ESCC participants in this study will be given intravenous administration of AK104 (10 mg/kg d1) combined with cisplatin (20 mg/m2 on d1-3) and albumin paclitaxel (100mg/m2 on d1, d8), fluorouracil (600 mg/m2 on d1-5) every three weeks for a cycle of treatment, which will be conducted two or three cycles, and radical surgery within 4-6 weeks after the last administration. Treatments will be administrated until disease progression, unacceptable adverse events (AE), concomitant diseases that hinder continued treatment.
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weijia Fang, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Akeso Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, Weijia Fang, MD, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947201
- Sponsor's protocol ID
- CAPITAL
- Status last verified
- Aug 2023
- First submitted
- 7 May 2023
- Last updated
- 8 Aug 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 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment of Cadonilimab Combined Albumin-paclitaxel, Cisplatin and Fluorouracil for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma：A Single-Arm Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT05947201
- Acronym / sponsor ID
- CAPITAL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Weijia Fang, MDUniversity, hospital or other
- Collaborators
- Akeso Pharmaceuticals, Inc.
- Study start
- 8 May 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 17 Jul 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 is a single-arm clinical study to evaluate the efficacy and safety of Cadonilimab in combination with preoperative chemotherapy for locally advanced esophageal squamous cell carcinoma Locally Advanced Esophageal Squamous Cell Carcinoma
Detailed description
Esophageal cancer is the eighth most lethal tumor and the sixth leading cause of cancer-related deaths worldwide. Esophageal squamous cell carcinoma accounts for up to 95% of the pathological types and threatens the health of chinese residents. Investigator designed a single-arm, open-label, phase II trial and the purpose of this study is to observe and evaluate the efficacy and safety of Cadonilimab combined with preoperative chemotherapy for locally advanced esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients fulfilling Eligibility Criteria will be included in our study. ESCC participants in this study will be given intravenous administration of AK104 (10 mg/kg d1) combined with cisplatin (20 mg/m2 on d1-3) and albumin paclitaxel (100mg/m2 on d1, d8), fluorouracil (600 mg/m2 on d1-5) every three weeks for a cycle of treatment, which will be conducted two or three cycles, and radical surgery within 4-6 weeks after the last administration. Treatments will be administrated until disease progression, unacceptable adverse events (AE), concomitant diseases that hinder continued treatment.
| Arm | Type | Receives |
|---|---|---|
| AK104+cisplatin+albumin paclitaxel+fluorouracil | Experimental | Drug: Cadonilimab Combined Albumin-paclitaxel, Cisplatin and FluorouracilAK104 (10 mg/kg d1), in combination with cisplatin (20 mg/m2 on d1-3) and albumin paclitaxel (100mg/m2 on d1,d8), fluorouracil (600 mg/m2 on d1-5) Q3W, intravenously |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants who have given their consent and signed an informed consent form, are willing and able to comply with the study visits, treatment, laboratory tests, and other trial procedures.
- Patients with a pathological diagnosis of (thoracic) esophageal squamous cell carcinoma.
- Age between 18 and 75 years (inclusive), both male and female.
- Locally advanced esophageal squamous cell carcinoma without suspicious cervical lymph node metastasis and distant metastasis (cT1N1-3M0 or cT2-3N0-3M0, AJCC 8th edition).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Key exclusion criteria (15 listed)
- History of or concurrent active malignancy other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer or other malignancy with no evidence of disease for at least 5 years.
- Active bleeding within 3 months; a history of arterial or venous thrombotic events within 6 months, such as stroke (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism; known inherited or acquired bleeding diathesis (e.g., coagulation factor deficiencies) or thrombotic disorders, such as patients with hemophilia; current or recent (within 10 days before the start of the study treatment) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes (allowed prophylactic use of low-dose aspirin and low-molecular-weight heparin); major surgery (excluding biopsy) within 4 weeks before starting study drug treatment or the surgical incision has not fully healed; current or recent (within 10 days before the start of the study treatment) use of aspirin (> 325 mg/day [maximum antiplatelet dose]) or other nonsteroidal anti-inflammatory drugs, dual antiplatelet therapy, clopidogrel, prasugrel, ticagrelor, or cilostazol.
- The patient has received systemic treatment, surgery, or radiotherapy for esophageal cancer, including immunotherapy such as anti-PD-1 or PD-L1 antibodies, anti-CTLA-4 antibodies, targeted therapy, or chemotherapy.
- The patient has used systemic corticosteroids or other systemic immunosuppressive drugs within 2 weeks before treatment, or is expected to use systemic immunosuppressive drugs during the trial. The use of inhaled glucocorticoids or physiological replacement doses of glucocorticoids is allowed.
- The patient has active autoimmune diseases. Patients with type 1 diabetes, hypothyroidism requiring replacement therapy only, skin diseases (such as vitiligo, psoriasis, or alopecia) that do not require systemic treatment or are not expected to recur without external triggering factors can be included in the trial.
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 |
|---|---|---|
| Cadonilimab Combined Albumin-paclitaxel, Cisplatin and FluorouracilAlso: rutineIf the addition of Cadonilimab to neoadjuvant chemotherapy further improve the efficiency for locally advanced esophageal squamous cell carcinoma | Drug | AK104+cisplatin+albumin paclitaxel+fluorouracil |
Primary outcome
pathologic complete response (pCR) of the patients' resected tumors
Time frame: 1 month after resection
PCR is defined as pT0N0M0
5 secondary outcomes
Major pathologic response (MPR)
Time frame: 1 month after resection
Disease Free Survival (DFS)
Time frame: 3 and 5 years
Overall Survival (OS)
Time frame: 3 and 5 years
pathological downstaging rate
Time frame: 1 month after resection
R0 resection rate
Time frame: 1 month after resection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for The Efficacy and Safety of Therapy Efficacy for Locally Advanced ESCC
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 2 study testing Cadonilimab Combined Albumin-paclitaxel, Cisplatin and Fluorouracil in people with The Efficacy and Safety of Therapy Efficacy for Locally Advanced ESCC, run by Weijia Fang, MD 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 14 inclusion and 15 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 8 Aug 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 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 Lu lu Liu, M.D. (0571-87237587, liululu2001@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response (pCR) of the patients' resected tumors (time frame: 1 month after resection). 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 8 Aug 2023.