To hear about similar clinical trials, please enter your email below
Trial Title:
Candonilimab (AK104) Plus Preoperative Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
NCT ID:
NCT05896787
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Paclitaxel
Carboplatin
Conditions: Keywords:
AK104
preoperative chemotherapy
surgery
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK104, nab-paclitaxel, carboplatin
Description:
AK104 plus nab-paclitaxel and carboplatin as neoadjuvant therapy，and AK104 as adjuvant
therapy for those who do not achieve pCR;
Arm group label:
AK104 plus nab-paclitaxel and carboplatin
Other name:
Candonilimab，Preoperative Chemotherapy
Summary:
This is a prospective, single-arm, open-label，multi-center, phase II study, aiming to
evaluate the efficacy and safety of AK104 combined with preoperative chemotherapy in
patients with locally advanced ESCC.
Detailed description:
Eligible patients first receive AK104 (10mg/kg, iv, Q2W) for one cycle in the induction
period, and then patients receive AK104 (10mg/kg, iv, Q3W) combined with nab-paclitaxel
(130mg/m2 ivgtt d1，d8, Q3W) and carboplatin ((AUC=5) d1，Q3W) for 2 cycles. After
neoadjuvant therapy of 3 cycles, patient will undergo preoperative evaluation. For
patients who can be performed for R0 surgery, surgery wil be performed in 4 to 6 weeks.
Patients who do not achieve Pathological complete response (pCR) will receive AK104
(10mg/kg, iv, Q3W) as adjuvant therapy until disease progression or intolerable toxicity
for up to 12 months. Patients who achieve pCR after surgery will be enrolled in
observational follow-up.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily signing a written informed consent form;
2. Males or females aged ≥ 18 to ≤ 70 years;
3. ECOG score 0-1;
4. Pathologically diagnosed thoracic esophageal squamous cell carcinoma;
5. No distant metastasis after imaging examination, and esophageal cancer can be
resected or potentially resectable with stage cT1b-cT2N+M0 or cT3-cT4a anyN M0 or
cT2N0M0 high-risk (lymphovascular invasion or tumor ≥3 cm or hypo-differentiation)
(AJCC 8th edition cTNM stage);
6. Not received prior antitumor therapy (surgery, radiotherapy, chemotherapy,
immunotherapy, etc. for esophageal cancer);
7. Life expectancy is greater than 6 months;
8. At least one measurable tumor lesion per RECIST v1.1;
9. Major organ functions are adequate;
Exclusion Criteria:
1. Patient has received previous antitumor therapy (chemotherapy, radiation, surgery or
immunotherapy);
2. Cervical or thoracic esophageal cancer is < 5 cm from the cricopharyngeal muscle;
3. Patients are or are expected to be at significant risk of esophageal perforation,
fistula, and major bleeding;
4. Imaging during the screening period showed that the tumor surrounded or invaded
important blood vessels or organs (such as the heart and pericardium, trachea,
aorta, superior vena cava, etc.) or there was obvious necrosis or cavity, and the
investigator determined that entering the study would cause bleeding risk;
participants at risk of developing oesophageal or oesophageal fistula;
5. Patients with a history of other malignant diseases in the last 5 years，unless
complete resolution or no additional treatment is required (exceptions include, but
are not limited to, basal or squamous cell skin cancer, superficial bladder cancer
or prostate, cervix, or breast carcinoma in situ)；
6. Pregnant or nursing women；
7. Patients with known or suspected active autoimmune disease;
8. Patients with a history of myocarditis, cardiomyopathy, malignant arrhythmias;
9. Other patients are not eligible for enrollment assessed by investigators;
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anyang Cancer Hospital
Address:
City:
Anyang
Zip:
450052
Country:
China
Contact:
Last name:
Anlin Hao
Facility:
Name:
Feng Wang
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Contact:
Last name:
Feng Wang
Start date:
August 1, 2023
Completion date:
August 1, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Source:
The First Affiliated Hospital of Zhengzhou University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05896787
