Clinical trial NCT06869226: A Multicenter Phase II Clinical Study of Neoadjuvant Use of Camrelizumab in Combination with Chemotherapy for Organ Preservation in Esophageal Cancer
Official title: A Multicenter Phase II Clinical Study of Neoadjuvant Use of Camrelizumab in Combination with Chemotherapy for Organ Preservation in Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Esophageal Cancer
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter phase II clinical study to explore the efficacy, safety, and organ preservation feasibility of camrelizumab in combination with chemotherapy for resectable esophageal squamous carcinoma in patients with histologically and pathologically confirmed resectable esophageal squamous carcinoma.


Eligibility criteria: Inclusion Criteria:

1. Subjects voluntarily enrolled in this study, signed the informed consent form, had good compliance, and could cooperate with follow-up visits;
2. esophageal cancer diagnosed by histopathology; clinical staging of cT1b-cT2 N+ M0 or cT3, any N, M0 (according to AJCC 8th edition);
3. Age 18-75 years old, male or female;
4. ECOG PS 0-1;
5. measurable tumor lesions or non-measurable lesions that can be evaluated;
6. not having received any previous anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc;
7. Normal or mildly to moderately abnormal lung function (VC%\>60%, FEV1\>1.2L, FEV1%\>40%, DLco\>40%) that can tolerate esophageal cancer resection;
8. No contraindications to surgery;
9. function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days): (1) Normal bone marrow reserve function with white blood cell (WBC) ≥3.0×109/L; neutrophil count (NEUT) ≥1.5×109/L, platelet count (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L; (2) Normal renal function with serum creatinine (SCr) ≤1.5 times upper limit of normal (ULN) or creatinine clearance ≥60 ml/min (Cockcroft-Gault formula); (3) Normal liver function with total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); and an albumin transaminase (AST) or alanine transaminase (ALT) level ≤2.5 times the upper limit of normal (ULN); (4) Normal coagulation function with International Normalized Ratio (INR) ≤ 1.5 times the upper limit of normal (ULN) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times the upper limit of normal (ULN).
10. Patients with potential childbearing potential are required to use a medically approved contraceptive method (e.g., IUD, birth control pills, or condoms) during and for 6 months after the end of the study treatment period; must have had a negative serum HCG or urine HCG test for 72 h prior to study entry; and must not be breastfeeding.

Exclusion Criteria:

1. Presence of locally advanced unresectable (regardless of stage) or metastatic disease (stage IV);
2. Exclude patients with cervical segment esophageal cancer;
3. Previous history of allergy to monoclonal antibodies, any component of karelizumab, albumin-bound paclitaxel, carboplatin or other platinum drugs;
4. patients with moderate or greater chest and back pain and risk of esophageal perforation.
5. have received or are receiving any of the following treatments in the past: (1) any radiotherapy, chemotherapy, or other antineoplastic agents directed against the tumor; (2) Treatment with immunosuppressive drugs, or systemic hormonal drugs for immunosuppression (doses \>10 mg/day prednisone or equivalent) within 2 weeks prior to first use of study drug; inhaled or topical steroids and adrenocorticotropic hormone replacement at doses \>10 mg/day prednisone or equivalent are permissible in the absence of active autoimmune disease; (3) Received a live attenuated vaccine within 4 weeks prior to first use of study drug; (4) Major surgery or severe trauma within 4 weeks prior to first use of study drug;
6. Have any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); patients with psoriasis or childhood asthma/allergies that have been in complete remission and do not require any interventions in adulthood may be considered for inclusion, but patients requiring bronchial Patients who require medical intervention with bronchodilators may not be included;
7. a history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;
8. the presence of clinically uncontrolled cardiac conditions or diseases, including but not limited to, such as (1) NYHA class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, and (4) clinically significant supraventricular or ventricular arrhythmia that is not clinically intervened with or remains poorly controlled after clinical intervention;
9. a serious infection (CTCAE grade 2) such as severe pneumonia requiring hospitalization, bacteremia, or infectious co-morbidities within 4 weeks prior to the first use of study drug; except for prophylactic antibiotic use if baseline chest imaging suggests the presence of active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of study drug, or the need for treatment with oral or intravenous antibiotics;
10. the presence of active tuberculosis infection by history or CT scan, or a history of active tuberculosis infection within 1 year prior to enrollment, or a history of active tuberculosis infection more than 1 year ago without regular treatment
11. Presence of active hepatitis B HBV DNA ≥ 2000 IU/mL or 104 copies/mL hepatitis C (hepatitis C antibody positive and HCV RNA above the lower detection limit of the analytical method);
12. other malignancies diagnosed within 5 years prior to first use of study drug, unless malignancies with a low risk of metastasis or risk of death (5-year survival \> 90%), such as adequately treated basal cell carcinoma of the skin or squamous cell skin carcinoma or carcinoma of the cervix in situ, may be considered for enrollment
13. Pregnant or lactating females;
14. In the judgment of the investigator, there are other factors that may lead to forced termination of the study in the middle of the study, such as suffering from other serious illnesses (including psychiatric illnesses) that require comorbid treatment, alcoholism, drug abuse, family or social factors that may affect the safety of or compliance with the subject.

Primary outcomes:
measure: Event-free survival (EFS)
timeFrame: about 2 years
Secondary outcomes:
measure: Clinical complete remission (cCR) rate
timeFrame: about 2 years
measure: Pathologic complete remission (pCR) rate
timeFrame: about 2 years
measure: Progression-free survival (PFS) in subjects with organ preservation strategies
timeFrame: about 2 years
measure: Overall survival (OS) in subjects with organ preservation strategies
timeFrame: about 2 years
measure: Adverse Events (AE)
timeFrame: about 2 years
Other outcomes:
Locations:
Study officials:
References: