BridgeMD
Tests treatment safety and results for Esophageal Cancer
Official title Efficacy and Safety of Penpulimab Combined With Anlotinib and Chemotherapy
ClinicalTrials.gov ID: NCT06586242
What this study is testing
What is Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin?
Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal cancer.
Also referred to as AK105；AL3818.
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 study is a two arm, randomized, prospective, multicenter study on the perioperative treatment of locally advanced resectable esophageal cancer with penpulimab combined with anlotinib hydrochloride and chemotherapy.
- 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
- 1\. only those who meet all the following requirements can be enrolled in this trial: 1. age 18-75 years old, both male and female;
- 2\. according to gastroscope / ultrasonic gastroscope biopsy, the pathology suggests esophageal cancer, and the clinical diagnosis is ct2n1-3m0 or...
- 3\. patients with non cervical esophageal cancer;
- 4\. have not received previous systemic and local treatment for esophageal cancer according to RECIST 1 1 criteria at least one measurable lesion was...
- 5.ecog PS: 0-1 point;
You likely can't join if
- 1\. 5 years of other malignant tumors, except for cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor [ta (non...
- 2\. patients with ulcerative esophageal squamous cell carcinoma;
- 3\. patients with esophageal fistula or tracheal fistula;
- 4\. those who are sensitive to anlotinib, pembrolizumab, albumin paclitaxel or oxaliplatin and excipients;
- 5\. have a history of immune deficiency, including HIV positive or suffering from other acquired or congenital immune deficiency diseases, or have a...
- 6\. patients with any severe and / or uncontrolled disease, including: 1) Patients with unsatisfactory blood pressure control (systolic blood...
See the full eligibility criteria
- 1\. only those who meet all the following requirements can be enrolled in this trial: 1. age 18-75 years old, both male and female;
- 2\. according to gastroscope / ultrasonic gastroscope biopsy, the pathology suggests esophageal cancer, and the clinical diagnosis is ct2n1-3m0 or ct3n0-3m0 or ct4n0-3m0, and the TNM stage is stage ii-iva;
- 3\. patients with non cervical esophageal cancer;
- 4\. have not received previous systemic and local treatment for esophageal cancer according to RECIST 1 1 criteria at least one measurable lesion was used for imaging evaluation of neoadjuvant therapy;
- 5.ecog PS: 0-1 point;
- 6\. estimated survival ≥ 12 months;
- 7\. the subject had no dysfunction of major organs, and the investigator assessed that the thyroid, lung, bone marrow, liver, kidney and heart functions were basically normal; 8. women of childbearing age must have...
- 9\. the people voluntarily joined the study, signed the informed consent, had good compliance, followed the planned schedule, actively cooperated with returning to the hospital for regular clinical follow-up and...
- 1\. 5 years of other malignant tumors, except for cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor [ta (non invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating...
- 2\. patients with ulcerative esophageal squamous cell carcinoma;
- 3\. patients with esophageal fistula or tracheal fistula;
- 4\. those who are sensitive to anlotinib, pembrolizumab, albumin paclitaxel or oxaliplatin and excipients;
- 5\. have a history of immune deficiency, including HIV positive or suffering from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation;
- 6\. patients with any severe and / or uncontrolled disease, including: 1) Patients with unsatisfactory blood pressure control (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mmHg); 2) Myocardial...
- 7\. unrelieved toxic reactions higher than CTCAE grade 1 due to any previous treatment, excluding hair loss;
- 8\. esophageal cancer patients with active bleeding within 2 months of the primary lesion;
- 9\. patients whose tumors have invaded the important blood vessels or are judged by the investigator to be very likely to invade the important blood vessels during the follow-up study and cause fatal massive hemorrhage;
- 10\. patients with multiple factors affecting oral drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), but patients with dysphagia who can drink water, can take anlotinib after...
- 11\. the urine routine indicates that the urine protein is ≥ + +, and the 24-hour urine protein quantitation is confirmed to be \>1.0 g;
- 12\. received major surgical treatment, incision biopsy or obvious traumatic injury within 28 days before grouping;
- 13\. abnormal coagulation function: inr\>1.5 or prothrombin time (PT) \>uln+4 seconds or APTT \>1.5uln), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; Within 4 weeks before grouping...
- 14\. Those who have had arterial / venous thrombotic events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
- 15\. pregnant or lactating women;
- 16\. patients with distant metastasis;
- 17\. patients with significant myelosuppression;
- 18\. have a history of mental illness or abuse of psychotropic drugs;
- 19\. Patients who have participated in clinical trials of other drugs within 4 weeks;
- 20\. according to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study;
- 21\. the investigator believes that it is not suitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaan'xi, China
Compensation & support
A stipend or compensation may be offered.
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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaan'xi, 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.