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New treatment option for Esophageal Squamous Cell Carcinoma
Official title Neoadjuvant ChemoRadiotherapy Followed by Immunotherapy and Surgery for Resectable Esophageal Squamous Cell Carcinoma（CRIS-2 Trial）
ClinicalTrials.gov ID: NCT06509568
What this study is testing
What is Neoadjuvant chemoimmunotherapy?
Neoadjuvant chemoimmunotherapy is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for esophageal squamous cell carcinoma.
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
- Based on our previous single-arm Phase Ib study (CRIS trial, NCT06303583), we observed that neoadjuvant chemoradiotherapy followed by immunotherapy (nCRIT) significantly increased the pathological complete response (pCR) rate, achieving approximately 60% in locally advanced esophageal squamous cell carcinoma(ESCC). We plan to initiate a multicenter, prospective, randomized phase II trial designed to compare the efficacy and safety of neoadjuvant chemoimmunotherapy (nCIT) versus neoadjuvant chemoradiotherapy followed by immunotherapy (nCRIT) in treating esophageal squamous cell carcinoma.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Age and Consent: people must be male or female, aged ≥18 and ≤75 years at the time of signing the informed consent form.
- Performance Status: people must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, or a Karnofsky Performance Status...
- Histological Confirmation: Histologically confirmed thoracic esophageal squamous cell carcinoma (ESCC), with the upper boundary of the lesion not...
- Resectability: people must have resectable or potentially resectable T3-4aN0 or T2-4aN+ ESCC, as per the AJCC/UICC 8th edition clinical staging...
- Lesion Length: The length of the esophageal lesion must be \<8 cm.
You likely can't join if
- Cervical esophageal cancer (lesion located in the cervical esophagus).
- Metastasis to cervical lymph nodes or lymph nodes around the celiac artery.
- Invasion of the trachea or aorta.
- Hoarseness caused by the esophageal tumor.
- Esophageal fistula or a tendency to develop an esophageal fistula.
- Pregnant or lactating patients.
See the full eligibility criteria
- Age and Consent: people must be male or female, aged ≥18 and ≤75 years at the time of signing the informed consent form.
- Performance Status: people must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, or a Karnofsky Performance Status (KPS) score of ≥80.
- Histological Confirmation: Histologically confirmed thoracic esophageal squamous cell carcinoma (ESCC), with the upper boundary of the lesion not exceeding the thoracic inlet.
- Resectability: people must have resectable or potentially resectable T3-4aN0 or T2-4aN+ ESCC, as per the AJCC/UICC 8th edition clinical staging (cTNM).
- Lesion Length: The length of the esophageal lesion must be \<8 cm.
- Surgical Eligibility: people must have no contraindications for surgical procedures.
- Organ Function: people must have good cardiopulmonary function and other organ functions to tolerate chemoradiotherapy and surgery. a. Hematology (without the use of any blood components and cell growth factor support...
- Female people of Childbearing Potential: Must have a negative urine or serum pregnancy test within 3 days prior to the first dose (if the urine pregnancy test is inconclusive, a serum pregnancy test will be required...
- Male people with Female Partners of Childbearing Potential: Must use effective contraception from the start of screening until 120 days after the last dose of the study drug. Decisions regarding contraception...
- Compliance: people must be adequately informed and sign the informed consent form. They must also be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.
- Cervical esophageal cancer (lesion located in the cervical esophagus).
- Metastasis to cervical lymph nodes or lymph nodes around the celiac artery.
- Invasion of the trachea or aorta.
- Hoarseness caused by the esophageal tumor.
- Esophageal fistula or a tendency to develop an esophageal fistula.
- Pregnant or lactating patients.
- Severe, poorly controlled diabetes mellitus.
- Inability to use the stomach for esophageal replacement due to previous surgeries.
- Previous receipt of chemoradiotherapy.
- Allergy or contraindication to taxane drugs.
- Inability to provide informed consent due to psychological, familial, or social reasons.
- History of malignancies other than esophageal cancer.
- Inability to tolerate chemoradiotherapy due to severe cardiac, pulmonary, hepatic, renal dysfunction, hematologic diseases, or cachexia; BMI \< 18.5.
- Active autoimmune disease, history of autoimmune disease (including but not limited to colitis, hepatitis, hyperthyroidism, etc.), history of immune deficiency (including positive HIV test), or other congenital or...
- Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10\^4 copies/mL), active hepatitis C (positive hepatitis C antibody with HCV-RNA levels above the detection limit).
- History of immunodeficiency; positive HIV antibody test; currently on long-term systemic corticosteroids or other immunosuppressants.
- Severe infections within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infections requiring systemic anti-infective therapy...
- Known active tuberculosis (TB); suspected active TB should be ruled out by clinical examination; known active syphilis infection.
- Receipt of live or attenuated live vaccines within 30 days prior to the first dose or planned receipt of such vaccines during the study period (inactivated vaccines are allowed).
- History of interstitial lung disease or non-infectious pneumonitis.
- History of myocarditis, cardiomyopathy, malignant arrhythmias; unstable angina requiring hospitalization, myocardial infarction, congestive heart failure (NYHA class 2 or above), or vascular disease (e.g., aneurysms at...
- Known psychiatric disorders, drug abuse, alcoholism, or a history of substance abuse.
- Local or systemic diseases caused by non-malignant tumors; or diseases or symptoms secondary to tumors that may lead to high medical risk and/or uncertainty in survival assessment, such as tumor leukemoid reaction...
- Any condition that the investigator believes may pose a risk to the subject's participation in the study, interfere with the evaluation of the study drug, or affect the interpretation of study results.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 Hangzhou, Zhejiang, 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.