NCT07263919
Recruiting
Phase 2
A Randomized, Controlled, Multi-center Phase II/III Clinical Trial of Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma (ESCC)
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Akeso
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Pathologic Complete Response (pCR) rate as assessed by the investigator
Overview
Brief Summary
This is a randomized, controlled, multi-center phase II/III study. All patients are resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of perioperative Cadonilimab combined with neoadjuvant chemotherapy versus neoadjuvant chemotherapy in patients with resectable ESCC.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
- •≥18 years old and ≤ 75 years (regardless of sex).
- •Pathologically confirmed esophageal squamous cell carcinoma, assessed as resectable.
- •Adequate pulmonary function.
- •Adequate tumor tissue samples.
- •ECOG performance status of 0-
- •Adequate organ function.
- •Within 7 days prior to the first dose, women of childbearing potential must have a negative urine or serum pregnancy test and agree to use effective contraception during the study treatment period and for 120 days after the last dose.
Exclusion Criteria
- •Presence of suspected distant metastatic lesions, or locally advanced unresectable disease.
- •Histologically confirmed as other pathological types.
- •Previous surgery precludes the use of gastric substitution for esophageal reconstruction in the current procedure.
- •History of other malignant tumors within the past 5 years.
- •Within 4 weeks prior to randomization, presence of conditions such as severe esophagogastric varices, active ulcers, unhealed wounds, gastrointestinal perforation, or intestinal obstruction.
- •Active or documented history of inflammatory bowel disease.
- •Clinically symptomatic or recurrent pleural, pericardial, or ascitic fluid requiring drainage.
- •Uncontrolled concurrent illnesses.
- •Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to randomization.
- •History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment.
Arms & Interventions
Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel
Experimental
Intervention: Cadonilimab (AK104) (Drug)
Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel
Experimental
Intervention: Cisplatin (Drug)
Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel
Experimental
Intervention: Paclitaxel (Drug)
Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel
Experimental
Intervention: Cadonilimab (AK104) (Drug)
Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel
Experimental
Intervention: Cisplatin (Drug)
Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel
Experimental
Intervention: Paclitaxel (Drug)
Cisplatin and Paclitaxel
Active Comparator
Intervention: Cisplatin (Drug)
Cisplatin and Paclitaxel
Active Comparator
Intervention: Paclitaxel (Drug)
Outcomes
Primary Outcomes
Pathologic Complete Response (pCR) rate as assessed by the investigator
Time Frame: Up to approximately 2 years
Proportion of subjects with no tumor residue in the primary tumor and regional lymph nodes.
Adverse Event (Phase II stage)
Time Frame: Up to approximately 5 years
Incidence and severity of adverse events (AEs), rate of delayed surgery, and clinically significant abnormal laboratory findings.
Secondary Outcomes
- Major Pathological Response (MPR) rate as assessed by the investigator(Up to approximately 2 years)
- R0 resection rate(Up to approximately 2 years)
- Event Free Survival (EFS)(Up to approximately 5 years)
- Disease Free Survival (DFS)(Up to approximately 5 years)
- Overall Survival (OS)(Up to approximately 5 years)
- Overall Response Rate (ORR)(Up to approximately 2 years)
- Disease Control Rate (DCR)(Up to approximately 2 years)
- Pharmacokinetics (PK)(Up to approximately 2 years)
- Anti-Drug Antibodies(ADAs)(Up to approximately 2 years)
Investigators
Study Sites (1)
Loading locations...
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