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Tests treatment safety and results for Resectable Esophageal Squamous Cell Carcinoma
Official title Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC
ClinicalTrials.gov ID: NCT07457528
What this study is testing
What is HLX10?
HLX10 is an investigational medicine, being studied as a potential treatment for resectable esophageal squamous cell carcinoma.
Also referred to as Serplulimab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial is conducted in patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 46 patients with resectable locally advanced esophageal cancer in Tianjin cancer hospital.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Sign an informed consent form.
- Age ≥ 18 years, ≤ 75 years, both genders are eligible.
- Patients with histologically confirmed clinical stage of locally advanced (cT1N2-3M0 or cT2-4aN0-3M0) thoracic esophageal squamous cell carcinoma...
- ECOG: 0-1.
- Expected to achieve R0 resection.
You likely can't join if
- Within the past six months, received EGFR monoclonal antibodies or EGFR-TKIs.
- Participated in other treatment clinical trials within 30 days prior to screening.
- Have severe comorbidities, such as heart failure, high-risk uncontrollable arrhythmias, severe myocardial infarction, refractory hypertension, renal...
- Patients with brain metastases with symptoms or symptom control for less than 3 months.
- History of other malignancies (except for cured in situ cervical cancer or skin basal cell carcinoma, and other malignancies cured for more than 5...
- Presence of active infection or active infectious disease.
See the full eligibility criteria
- Sign an informed consent form.
- Age ≥ 18 years, ≤ 75 years, both genders are eligible.
- Patients with histologically confirmed clinical stage of locally advanced (cT1N2-3M0 or cT2-4aN0-3M0) thoracic esophageal squamous cell carcinoma (8th UICC-TNM staging).
- ECOG: 0-1.
- Expected to achieve R0 resection.
- No prior treatment for the primary esophageal tumor, including drug therapy, surgery, and radiotherapy.
- No suspicious metastatic lymph nodes in the neck as suggested by neck enhanced CT or neck ultrasound; no systemic metastasis on imaging studies.
- Measurable lesions according to RECIST 1.1 criteria.
- Important organ functions meet the following requirements:
- Absolute neutrophil count ≥ 1.5×10\^9, platelets ≥ 80×10\^9, hemoglobin ≥ 90g/L;
- Total bilirubin level ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN (for patients with liver metastasis, AST and ALT levels ≤ 5...
- Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula);
- Serum albumin ≥ 28g/L;
- Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);
- Pulmonary function: FEV1/FVC ≥ 70%, FEV1 ≥ 50% of normal value, DLCO (diffusing capacity of the lung for carbon monoxide) measured value to predicted value percentage \> 80%.
- Women of childbearing age must agree to use contraception (such as intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after the study ends; negative serum or urine pregnancy test...
- Must understand and sign the informed consent form.
- Within the past six months, received EGFR monoclonal antibodies or EGFR-TKIs.
- Participated in other treatment clinical trials within 30 days prior to screening.
- Have severe comorbidities, such as heart failure, high-risk uncontrollable arrhythmias, severe myocardial infarction, refractory hypertension, renal failure (CKD stage 4 or higher), thyroid dysfunction, mental...
- Patients with brain metastases with symptoms or symptom control for less than 3 months.
- History of other malignancies (except for cured in situ cervical cancer or skin basal cell carcinoma, and other malignancies cured for more than 5 years).
- Presence of active infection or active infectious disease.
- Multifocal esophageal malignant tumors or presence of esophageal fistula or perforation signs.
- Imaging shows tumor invasion of important blood vessels, or the investigator determines that the tumor is highly likely to invade important blood vessels during the subsequent study period, leading to fatal major...
- Allergy to the drugs used in this protocol or their components.
- According to the Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0), peripheral neuropathy or hearing loss of grade ≥2.
- Pregnant or breastfeeding women.
- Those with a history of psychiatric drug abuse and unable to quit, or patients with mental disorders.
- Those deemed unsuitable for this study by the investigator.
- Those unwilling to participate in this study or unable to sign the informed consent form.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.