Efficacy and Safety of Penpulimab Combined With Anlotinib and Chemotherapy

NCT06586242 | Recruiting Phase 2 DMC

• 1 other identifier: TQXB-E-002
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• the Pathological complete response (PCR) rate

  Pathological complete response (PCR) rate

  2years

Secondary Outcomes (3)

• the rate of R0 resection

  2years

• Disease free survival time

  2years

• 1-year OS rate

  2years

Study Arms (2)

penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and oxaliplatin

EXPERIMENTAL

penpulimab：200mg, intravenous infusion, 30-60 minutes per infusion, once every 3 weeks, administered on the first day of each cycle anlotinib hydrochloride：Body weight \<60kg, 8mg Po, body weight ≥ 60kg, 10mg Po, D 1-14, q3w Albumin paclitaxel: 260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, d 1 medication per week oxaliplatin：130mg/m2, i.v., administered after albumin paclitaxel, on day 1 of each week; Three weeks is a treatment cycle.

Drug: Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin

penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and lobaplatin

ACTIVE COMPARATOR

penpulimab：200mg, intravenous infusion, 30-60 minutes per infusion, once every 3 weeks, administered on the first day of each cycle anlotinib hydrochloride：Body weight \<60kg, 8mg Po, body weight ≥ 60kg, 10mg Po, D 1-14, q3w Albumin paclitaxel: 260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, d 1 medication per week lobaplatin：50mg/m2, i.v., administered after albumin paclitaxel, on day 1 of each week; Three weeks is a treatment cycle.

Drug: Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin

Interventions

Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin DRUG

200mg, intravenous infusion, 30-60 minutes per infusion, once every 3 weeks, Penpulimab:administered on the first day of each cycle Anlotinib:Body weight \<60kg, 8mg Po, body weight ≥ 60kg, 10mg Po, D 1-14, q3w

Also known as: AK105；AL3818

penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and lobaplatin; penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and oxaliplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. only those who meet all the following requirements can be enrolled in this trial: 1. age 18-75 years old, both male and female;
• \. 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;
• \. patients with non cervical esophageal cancer;
• \. 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;
• ecog PS: 0-1 point;
• \. estimated survival ≥ 12 months;
• \. 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;
• \. 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.

You may not qualify if:

• \. 5 years of other malignant tumors, except for cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor \[ta (non invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
• \. patients with ulcerative esophageal squamous cell carcinoma;
• \. patients with esophageal fistula or tracheal fistula;
• \. those who are sensitive to anlotinib, pembrolizumab, albumin paclitaxel or oxaliplatin and excipients;
• \. 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;
• \. patients with any severe and / or uncontrolled disease, including:
• \) 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.
• \. unrelieved toxic reactions higher than CTCAE grade 1 due to any previous treatment, excluding hair loss;
• \. esophageal cancer patients with active bleeding within 2 months of the primary lesion;
• \. 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;
• \. 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;
• \. the urine routine indicates that the urine protein is ≥ + +, and the 24-hour urine protein quantitation is confirmed to be \>1.0 g;
• \. received major surgical treatment, incision biopsy or obvious traumatic injury within 28 days before grouping;
• \. 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;
• \. 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;

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

The First Affiliated Hospital of the Air Force Medical University

Xi'an, Shaan'xi, 710000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Liu Hong, Master

  The First Affiliated Hospital of Air Force Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Hong, Master

CONTACT

18792807591; 18792804403@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: April 3, 2023
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 1, 2036
• Last Updated: September 19, 2024

Record last verified: 2024-04

Locations

CN (1)