Clinical trial NCT06475196: Prospective Cohort Study of Neoadjuvant Therapy With Sintilimab (PD-1 Inhibitor) Combined With Chemotherapy in Resectable ESCC
Official title: The Prospective Cohort Study of Neoadjuvant Therapy With Sintilimab (PD-1 Inhibitor) Combined With Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Resectable Esophageal Squamous Cell Carcinoma
Keywords: neoadjuvant therapy
PD-1 inhibitor
resectable esophageal squamous cell carcinoma
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is an open-label, prospective, cohort clinical study to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer

Brief summary: This study is an open-label, prospective, cohort clinical study to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer. In the study, all subjects who meet the enrollment criteria will be randomized 1:1:1 to receive sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles (Group A), sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles + sintilimab for 1 cycle (Group B), sintilimab combined with platinum-containing chemotherapy for 1 cycle + sintilimab Q3W for 2 cycles (Group B) as neoadjuvant therapy, and receive radical surgery within 4-6 weeks after the completion of the last neoadjuvant therapy. Whether the subjects need adjuvant therapy and adjuvant treatment regimen after surgery are determined by the investigator, and all subjects need to complete the follow-up plan formulated by the study after surgery.


Eligibility criteria: Inclusion Criteria:

1. Preoperative gastroscopy showed that the main body of the tumor was located.
2. Patients with potentially resectable esophageal cancer evaluated by preoperative imaging (chest contrast-enhanced CT, head CT or MRI, abdominal B-ultrasound, PET/CT), and the potentially resectable patients refer to the 2018 edition of the Diagnosis and Treatment Standards for Esophageal Cancer formulated by the National Health and Wellness Commission, defined as patients with esophageal cancer stage T2-3, N0/N+, M0 or T4a, N0-1, M0 (8th edition AJCC stage in 2017).
3. Signed informed consent and met all the inclusion criteria of this study. 4）aged 18\~75 years old 5）ECOG PS score of 0-1;

Exclusion Criteria:

1. prior treatment with immune checkpoint inhibitors, including but not limited to anti-CTLA-4, anti-PD-1 and anti-PD-L1 therapeutic antibodies, and OX-40;
2. .previous systemic therapy;
3. current participation in an interventional clinical trial or receipt of another investigational drug or medical intervention within 4 weeks;
4. presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction (or other factors affecting the absorption of oral medications such as inability to swallow, nausea and vomiting, abnormal physiologic function, malabsorption syndrome, etc.) that require clinical intervention
5. the presence of any signs or history of bleeding constitution; the presence of unhealed wounds, ulcers, or fractures in patients who have experienced any bleeding or hemorrhagic event ≥ CTCAE Grade 3 within 4 weeks prior to enrollment; -

Primary outcomes:
measure: complete pathologic response (pCR)
timeFrame: 3 mouths
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital of the Fourth Millitary Medical University
state: Shaanxi
Study officials:
References: