Patients with advanced esophageal squamous cell carcinoma who have failed the first-line standard treatment and are positive for EGFR
Conditions
Interventions
Experimental group:Pucotenlimab+Anti-EGFR Monoclonal Antibody+MRG003
Control group:The treatment chosen by the researchers
Safe import:Pucotenlimab+Anti-EGFR Monoclonal Antibody+MRG003
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 75 years old, gender not restricted; 2. ECOG score: 0 - 1; 3. Histologically or cytologically confirmed as esophageal squamous cell carcinoma; 4. Available archived tumor specimens or biopsy specimens; 5. Immunohistochemical detection of EGFR positive; 6. Failure of first-line standard treatment (Note: Disease progression during neoadjuvant/adoptive therapy, or disease progression within 6 months after the end of neoadjuvant/adoptive therapy, is regarded as failure of first-line treatment.); 7. The primary tumor can be evaluated. According to RECIST 1.1, at least one measurable lesion must exist; 8. The expected survival period is >= 3 months; 9. The main organ functions are normal, which meet the following criteria: (1) Blood routine examination: a) HBG >= 90g/L; b) ANC >= 1.5 × 10^9/L; c) PLT >= 80 × 10^9/L; (2) Biochemical examination: a) ALB >= 30g/L; b) ALT and AST = 60ml/min; (3) Coagulation system examination: a) PT = 70%, FEV1 >= 50% of the normal value, and the percentage of the measured value of DLCO (pulmonary diffusion function) to the predicted value is > 80%; (5) Cardiac function: LVEF >= 50%, QTcF for males <= 450ms / for females <= 470ms. 10. Pregnant women of childbearing age must undergo pregnancy tests 7 days before starting treatment and the results must be negative; 11. All enrolled patients must take adequate contraceptive measures throughout the treatment period and within 6 months after the last treatment; 12. There are no severe hematological, cardiac function abnormalities and immune deficiencies; 13. There is no esophageal perforation and active esophageal bleeding, no invasion of the trachea, thoracic aorta or major thoracic vessels;
Exclusion criteria
Exclusion criteria: 1. Has a history of allergy to any component of the studied drug; 2. The patient has any active autoimmune disease or has an autoimmune disease (as listed below, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; the patient has vitiligo; the patient's asthma has been completely relieved in childhood and no intervention is required in adulthood can be included; patients with asthma who require bronchodilators for medical intervention cannot be included); 3. The patient is using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose > 10mg/day prednisone or other drugs with equivalent efficacy), and is still using them within 2 weeks before enrollment; 4. Active, known or suspected autoimmune diseases or a history of the disease within the past 2 years (patients with hypothyroidism requiring thyroid hormone replacement therapy and patients with type 1 diabetes requiring insulin replacement therapy can be included); 5. Has received MMAE/MMAF type ADC drugs before; 6. Has received any of the following treatments: (1) Used chemotherapy, biological therapy, targeted therapy, or immunotherapy (mitomycin and nitrosourea drugs within 6 weeks before the first administration, fluorouracil drugs such as tegafur, capecitabine etc. within 2 weeks before the first administration, other chemotherapy drugs within 3 weeks before the first administration; small molecule targeted drugs within 2 weeks before the first administration; biological therapy, large molecule targeted therapy and immunotherapy drugs within 4 weeks before the first administration) before the first administration; (2) Received local radiotherapy within 4 weeks before the first administration; (3) Received a strong CYP3A4 inhibitor or inducer within 2 weeks before the first administration; (4) Had a major surgery within 14 days before the first administration and has not fully recovered, or plans to undergo a major surgery within the first 12 weeks after receiving the study drug; 7. Has central nervous system metastasis; Note: For patients with central nervous system metastasis, if they have received brain metastasis radiotherapy in the past, the patient's condition is stable (no imaging progression within 4 weeks before the first administration and no neurological symptoms, and no new brain metastases or increase in existing brain metastases have been confirmed by imaging review, and no steroid treatment is required within 14 days before the first administration), then they can participate in the trial. If the patient has cancerous meningitis, regardless of whether their clinical condition is stable, they should be excluded; 8. Has toxic reactions or laboratory test abnormalities >= grade 2 (CTCAE v5.0); Note: Hair loss and skin pigmentation are excluded; or toxic reactions produced by previous treatment, such as hypothyroidism, without clinical symptoms after thyroid hormone replacement therapy, can also participate in this study; 9. Grade 2 peripheral neuropathy (CTCAE v5.0); 10. Liver function Child-Pugh grade B or C; 11. Has clinical symptoms that require drainage of pleural or peritoneal effusion or pericardial effusion; 12. Any severe or uncontrollable systemic disease, including poorly controlled hypertension (systolic pressure > 160 mmHg or diastolic pressure > 100 mmHg), poorly controlled diabetes (glycated hemoglobin >= 7%), a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Benefit Rate (CBR);Adverse event;Progression Free Survival, PFS;Overall survival, OS ;Disease control rate, DCR; | — |
Countries
China
Contacts
Public ContactLiu Yang
Zhejiang Provincial People's Hospital
Outcome results
None listed