Neoadjuvant camrelizumab plus chemotherapy to preserve the esophagus in resectable esophageal squamous carcinoma

A Multicenter Phase II Clinical Study of Neoadjuvant Use of Camrelizumab in Combination With Chemotherapy for Organ Preservation in Esophageal Cancer

This trial will test whether giving camrelizumab with nab-paclitaxel and cisplatin before surgery helps people with resectable esophageal squamous cancer preserve their esophagus and tolerate surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 283 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking University Cancer Hospital & Institute (Academic / other)
• Drugs / interventions: karelizumab, chemotherapy, prednisone, camrelizumab
• Locations: 1 site (Beijing)
• Trial ID: NCT06869226 on ClinicalTrials.gov

What this trial studies

This is a multicenter phase II trial led by Peking University Cancer Hospital testing neoadjuvant camrelizumab combined with nab-paclitaxel and cisplatin in patients with resectable esophageal squamous carcinoma. Eligible patients receive the immunotherapy-plus-chemotherapy regimen prior to planned surgical resection to measure tumor response, safety, and the feasibility of organ-preserving approaches. Key enrollment criteria include clinical stage cT1b-cT2 N+ M0 or cT3 any N M0, age 18–75, ECOG 0–1, and adequate organ function with no prior anti-tumor therapy for the cancer. Outcomes will include pathologic response, rates of organ-preserving surgery, and treatment-related adverse events.

Who should consider this trial

Good fit: Adults 18–75 with histologically confirmed resectable esophageal squamous carcinoma (cT1b-cT2 N+ M0 or cT3 any N M0), ECOG 0–1, adequate organ function, no prior anti-cancer therapy, and who are candidates for surgery.

Not a fit: Patients with unresectable or metastatic disease, poor performance status, major organ dysfunction, or prior treatment for the current cancer are unlikely to benefit from this neoadjuvant regimen.

Why it matters

Potential benefit: If successful, this approach could increase the chance patients keep their esophagus and reduce the extent of surgery needed.

How similar studies have performed: Neoadjuvant chemotherapy combined with PD-1 inhibitors has shown encouraging pathologic response rates in esophageal cancer, though camrelizumab-specific neoadjuvant data remain limited and further confirmation is needed.

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.

Where this trial is running

Beijing

• Peking University Cancer Hospital — Beijing, China (Recruiting)

Conditions Esophageal Cancer