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New treatment option for Lung Cancer
Official title A Multi Tumor, Open Phase I Clinical Study on the Progression of First-line Anti-tumor Therapy Using Cardonizumab Combined With Pulsed Low-dose Rate External Irradiation (PLDR)
ClinicalTrials.gov ID: NCT06232083
What this study is testing
- What it's testing
- At present, the treatment methods for recurrent cancers are very limited. The immune checkpoint inhibitors (ICBs) is a promising new directions for recurrent lung cancer/ esophageal cancer / cervical cancer, but the clinical response rate is insufficient.
- Phase 1: an early, usually small safety study
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. Healthy volunteers may be eligible.
You may be able to join if
- Patients must meet all the following criteria to be enrolled:
- The people voluntarily joined the study, signed informed consent, had good compliance and were willing to cooperate with the follow-up;
- There is no limit for men and women, ranging in age from 18 to 75 years old (including 18 and 75 years old);
- Pathologically confirmed esophageal cancer, lung cancer or cervical cancer;
- The expected survival time was more than 3 months;
You likely can't join if
- If the patient meets any of the following conditions, he cannot be selected:
- Patients with malignant tumors other than esophageal cancer, lung cancer and cervical cancer;
- Patients with other active malignant tumors in the first 5 years of randomization, such as squamous cell carcinoma of the skin, basal cell carcinoma...
- Patients who had participated in clinical trials of other drugs within 4 weeks before enrollment, and who had received radiotherapy for the target...
- Arteriovenous thrombosis events occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral...
- Receiving any other anti-tumor treatment at the same time;
See the full eligibility criteria
Who can join
- Patients must meet all the following criteria to be enrolled:
- The people voluntarily joined the study, signed informed consent, had good compliance and were willing to cooperate with the follow-up;
- There is no limit for men and women, ranging in age from 18 to 75 years old (including 18 and 75 years old);
- Pathologically confirmed esophageal cancer, lung cancer or cervical cancer;
- The expected survival time was more than 3 months;
- Recurrent or metastatic patients with previous treatment progress;
- ECoG 0-2 points;
- According to RECIST 1.1 standard, there was at least one extracranial measurable lesion;
- The laboratory test results within one week before enrollment meet the following conditions: 1) blood routine: HGB≥90g/L； WBC ≥ 4.0 × 109/L; Neut ≥ 2.0 × 109/l; PLT ≥ 100 × 109/l; 2) Blood biochemistry: TBIL ≤ 1.5 ×...
- The coagulation function was normal without active bleeding and thrombosis;
- Patients without contraindications to radiotherapy;
- The pregnancy test of patients of childbearing age was negative, and they voluntarily took effective and reliable contraceptive measures during the test;
- people who have received anti-tumor treatment in the past should not be enrolled until the toxicity of previous treatment has stabilized and returned to the baseline level (except for the residual hair loss effect) or...
What rules you out
- If the patient meets any of the following conditions, he cannot be selected:
- Patients with malignant tumors other than esophageal cancer, lung cancer and cervical cancer;
- Patients with other active malignant tumors in the first 5 years of randomization, such as squamous cell carcinoma of the skin, basal cell carcinoma of the skin, superficial bladder cancer, and breast cancer in situ...
- Patients who had participated in clinical trials of other drugs within 4 weeks before enrollment, and who had received radiotherapy for the target area within 4 weeks before entering this study, were vaccinated with...
- Arteriovenous thrombosis events occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism...
- Receiving any other anti-tumor treatment at the same time;
- Those who are known to have a history of allergy to the drug components of this protocol have a history of telangiectatic ataxia or other radiation hypersensitivity;
- people with active infectious diseases;
- people with any severe and/or uncontrolled disease;
- Female patients during pregnancy and lactation, female patients with fertility and positive baseline pregnancy test;
- According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension...
- Having a clear history of neurological or mental disorders, including epilepsy or dementia, and unable to cooperate with the radiotherapy process;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Diagnosed with immune deficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy, and suffering from active or recurrent autoimmune diseases, except for vitiligo, alopecia...
- Have active or documented inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), and active diverticulitis. The clinical manifestations of gastrointestinal obstruction, or the need for conventional...
- There were symptomatic central nervous system (CNS) metastasis, leptomeningeal metastasis or spinal cord compression caused by metastasis before signing the informed consent. Those without clinical symptoms, who have...
- At present, there are patients with effusion in the third space who need repeated puncture and drainage and other local treatment with poor clinical control;
- people with any of the following cardiovascular diseases were excluded:
- Myocardial infarction, unstable angina pectoris, pulmonary embolism, acute/persistent myocardial ischemia, cerebrovascular accident, transient ischemic attack, or other arteriovenous thrombosis, embolism or ischemic...
- Previous and/or current NYHA III-IV congestive heart failure;
- Previous and/or current severe arrhythmias requiring medical treatment;
- Before the first administration, 12 lead ECG showed that the mean QT interval (QTCF)\>470 Ms.
- The investigator believes that the patient is not suitable for any other circumstances in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, British Columbia, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, British Columbia, 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.