Combining penpulimab, anlotinib, and chemotherapy for esophageal cancer treatment

A Two Arm, Randomized, Prospective, Multicenter Study of Penpulimab Combined With Anlotinib Hydrochloride and Chemotherapy in the Perioperative Treatment of Locally Advanced Resectable Esophageal Cancer

This study is testing if a new combination of medications, including penpulimab and anlotinib, can improve treatment for people with advanced esophageal cancer before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xijing Hospital (Academic / other)
• Drugs / interventions: pembrolizumab, anlotinib, penpulimab, chemotherapy
• Locations: 1 site (Xi'an, Shaan'xi)
• Trial ID: NCT06586242 on ClinicalTrials.gov

What this trial studies

This clinical trial is a two-arm, randomized, prospective, multicenter study focusing on the perioperative treatment of locally advanced resectable esophageal cancer. Participants in the experimental group will receive penpulimab combined with anlotinib hydrochloride and chemotherapy agents albumin paclitaxel and oxaliplatin, while the control group will receive a similar regimen with lobaplatin instead of oxaliplatin. The study aims to evaluate the efficacy and safety of these combinations in improving treatment outcomes for patients with specific stages of esophageal cancer.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with locally advanced resectable esophageal cancer who have not received prior systemic or local treatment.

Not a fit: Patients with cervical esophageal cancer or those with significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could improve survival rates and quality of life for patients with locally advanced esophageal cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in treating various cancers, suggesting potential for success in this approach.

Eligibility criteria

Inclusion 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 taken reliable contraceptive measures or had a pregnancy test (serum or urine) within 7 days before enrollment, and the results are negative, and are willing to use appropriate methods of contraception during the test and - 8 weeks after the last administration of test drugs. For men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial and 8 weeks after the last administration of the trial drug;
* 9\. the subjects 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 necessary treatment, and cooperated with regular blood and tissue sample acquisition.

Exclusion Criteria:

* 1\. 5 years of other malignant tumors, except for cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor \[ta (non invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
* 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 ischemia or myocardial infarction of grade I or above; 3) Arrhythmia (including QT interval ≥ 480 MS) and grade I cardiac insufficiency; 4) Diabetes mellitus with poor blood glucose control (fasting blood glucose (FBG) \>10mmol/l) or high-dose glucocorticoid treatment; 5) Active or uncontrolled severe infection; 6) Decompensated liver disease, active hepatitis B (HBV-DNA ≥ 104copies/ml or 2000iu/ml) or hepatitis C (hepatitis C antibody and HCV RNA positive) were all above the lower limit of the analysis method; 7) Hyperthyroidism and hypothyroidism; 8) Active tuberculosis.
* 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 dissolving the particles;
* 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, patients with any bleeding or bleeding events ≥ CTCAE grade 3 had unhealed wounds, ulcers or fractures;
* 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.

Where this trial is running

Xi'an, Shaan'xi

• The First Affiliated Hospital of the Air Force Medical University — Xi'an, Shaan'xi, China (Recruiting)

Study contacts

• Principal investigator: Liu Hong, Master — The First Affiliated Hospital of Air Force Medicial University
• Study coordinator: Liu Hong, Master

Conditions Esophageal Cancer