Trials Sponsors Conditions Drugs Pricing

Conditions

The Efficacy and Safety of Therapy Efficacy for Locally Advanced ESCC

Outcome Measures

Primary Outcomes (1)

pathologic complete response (pCR) of the patients' resected tumors
PCR is defined as pT0N0M0
1 month after resection

Secondary Outcomes (5)

Major pathologic response (MPR)
1 month after resection
Disease Free Survival (DFS)
3 and 5 years
Overall Survival (OS)
3 and 5 years
pathological downstaging rate
1 month after resection
R0 resection rate
1 month after resection

Study Arms (1)

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

Drug: Cadonilimab Combined Albumin-paclitaxel, Cisplatin and Fluorouracil

Interventions

Cadonilimab Combined Albumin-paclitaxel, Cisplatin and FluorouracilDrug

If the addition of Cadonilimab to neoadjuvant chemotherapy further improve the efficiency for locally advanced esophageal squamous cell carcinoma

Also known as: rutine

AK104+cisplatin+albumin paclitaxel+fluorouracil

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Cadonilimab Combined Albumin-paclitaxel, Cisplatin and Fluorouracil
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Weijia Fang, MD
Otherlead
Akeso Pharmaceuticals, Inc.
Othercollaborator

Study Sites (1)

Lulu Liu

Hanzhou, Zhejiang, 0571, China

RECRUITING

Lu lu Liu, M.D.CONTACT0571-87237587 liululu2001@zju.edu.cn

MeSH Terms

Interventions

CisplatinFluorouracil

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Lu lu Liu, M.D.

CONTACT

0571-87237587 liululu2001@zju.edu.cn

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Oncology Department director

Study Record Dates

First Submitted

May 7, 2023

First Posted

July 17, 2023

Study Start

You may not qualify if:

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.
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.

Neoadjuvant Treatment of Cadonilimab Combined Albumin-paclitaxel, Cisplatin and Fluorouracil for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

AK104+cisplatin+albumin paclitaxel+fluorouracil

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

AK104+cisplatin+albumin paclitaxel+fluorouracil

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations