Search / Trial NCT06229041

Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi)

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Jan 26, 2024

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Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Rectal Cancer High Risk Immunotherapy

ClinConnect Summary

The Total Neoadjuvant Treatment ± Immunotherapy trial (TNTi) is a clinical study aimed at finding out which treatment approach is more effective for patients with high-risk locally advanced rectal cancer. The researchers want to see how well the treatments work by measuring the rate of complete tumor disappearance (called PCR) and how long patients remain cancer-free after three years. Participants will receive a combination of chemotherapy and radiation, with some also getting immunotherapy, before undergoing surgery.

To join the study, participants must be between 18 and 75 years old and diagnosed with a specific type of rectal cancer. They should not have had previous treatments for rectal cancer or certain other health issues that might complicate their participation. Those who enroll can expect to receive close monitoring and support throughout their treatment journey. The trial is currently looking for volunteers, and it’s important for interested patients to discuss their eligibility with their healthcare team.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • 1. \>18，\<75 years old
  • • 2. ECOG score 0-1
  • • 3. colorectal adenocarcinoma confirmed by pathology
  • • 4. The distance between the lower margin of the tumor and the anal margin is ≤12cm or the distance between the anorectal ring (ARJ) is ≤8cm
  • • 5. The initial local MRI stage was T4b, or mrN2, or positive MRF, or positive EMVI, or lateral lymph node metastasis (mrLLND+)
  • • 6. No evidence of distant metastasis
  • • 7. No history of pelvic radiotherapy
  • • 8. No history of rectal cancer surgery or chemotherapy
  • • 9. Systemic infections that do not require antibiotic treatment
  • • 10. Not associated with immune system diseases
  • • 11. Blood routine: ANC\>1.5 cells/mm3, HGB\>9.0g /dL, PLT\>800,000/mm3
  • • 12. Blood biochemistry: total bilirubin ≤1.5xULN, AST≤2.5xULN, ALT≤2.5xULN;
  • • 13. Serum creatinine ≤1.5 times the upper limit of normal and endogenous creatinine clearance ≥50mL/min (Cockcroft-Gault formula)
  • • 14. Patients with well-controlled hypertension were allowed to be enrolled
  • • 15. International Standardized ratio (INR), activated partial thromboplastin time (aPTT) ≤1.5 times the upper limit of normal value (only applicable to patients who have not received anticoagulant therapy; Patients receiving anticoagulant therapy should keep anticoagulants within the therapeutic requirements)
  • • 16. Normal or abnormal FT3, FT4 and TSH have no clinical significance
  • • 17. Normal cardiac function, that is, normal or abnormal ECG examination has no clinical significance, and left ventricular ejection fraction (LVEF) shown by cardiac ultrasound is greater than 50%
  • • 18. The patient read and signed the informed consent of this study and agreed to participate in this study
  • • 19. The subjects voluntarily joined the study, signed the informed consent, had good compliance and cooperated with the follow-up. It is recommended that all patients provide tumor tissue samples (preferably fresh) for pathological/genetic testing prior to enrollment
  • • 20. Fertile men or women with the possibility of becoming pregnant must use a highly effective contraceptive method throughout the trial and continue contraception for 12 months after the end of treatment
  • Exclusion Criteria:
  • • 1. Recurrent rectal cancer
  • • 2. Microsatellite instability (MSI) or mismatch repair gene deletion (dMMR)
  • • 3. The patient has had other malignancies in the past 5 years (in addition to properly treated basal cell carcinoma and skin squamous cell carcinoma)
  • • 4. The patient has had arterial embolic diseases in the past 6 months, such as angina pectoris, MI, TIA, CVA, etc.
  • • 5. Have received other types of anti-tumor or experimental therapy
  • • 6. The patient is a pregnant or lactating woman
  • • 7. The patient has other diseases or mental disorders that may affect the patient's participation in this study
  • • 8. Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy or VEGFR TKI therapy.
  • • 9. Major surgical procedures were performed/received within 4 weeks prior to the first administration of the study drug or the side effects of which have not yet recovered, live vaccination, immunotherapy, and radiotherapy within 2 weeks.
  • • 10. Study patients who had received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week before the first administration of the drug.
  • • 11. Known allergy to the investigational drug and its components
  • • 12. Active lung disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or a history of active tuberculosis.
  • 13. Have any clinical problems beyond your control, including but not limited to:
  • • a persistent or active (severe) infection b Poorly controlled hypertension (persistent blood pressure greater than 150/90 MMHG) c Poorly controlled diabetes mellitus d Heart disease (Grade III/IV congestive heart failure or heart block as defined by the Heart Society of New York) e Have or suspect an autoimmune disease, or a history of autoimmune disease or syndromes requiring treatment with a steroid/immunosuppressive system, such as hypophysitis, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.;
  • • 14. Other severe, acute, or chronic medical conditions or abnormalities in laboratory tests that the investigator determines may increase the risk associated with study participation or may interfere with the interpretation of the study results.

About Peking University Cancer Hospital & Institute

Peking University Cancer Hospital & Institute is a leading research and treatment facility dedicated to advancing oncology through innovative clinical trials and comprehensive patient care. Renowned for its commitment to cancer research, the institution integrates cutting-edge scientific exploration with clinical practice to enhance treatment outcomes and improve quality of life for cancer patients. With a multidisciplinary team of experts, Peking University Cancer Hospital & Institute focuses on developing novel therapeutic strategies and diagnostic tools, contributing significantly to the global fight against cancer. Its collaborative approach fosters partnerships with academic institutions and industry leaders, facilitating the translation of research findings into effective clinical applications.

Locations

Beijing, , China

Beijing, Beijing, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0