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

NCT06229041 | Recruiting Phase 3

• 1 other identifier: PKUCH R07
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the PCR rate between Total Neoadjuvant Treatment ±Immunotherapy in high risk locally advanced rectal cancer. The main questions it aims to answer are:

• The PCR rate between the two groups
• The 3years DFS between the two groups
• Chemoradiotherapy and immunotherapy toxicity
• Postoperative complications Participants will receive total neoadjuvant treatment ±immunotherapy followed by surgery. Researchers will compare neoadjuvant treatment ±immunotherapy to see the PCR rate.

Conditions

Rectal Cancer

Keywords

Rectal Cancer; High risk; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• The PCR rate between total neoadjuvant treatment ±immunotherapy

  2 years

Study Arms (2)

Total Neoadjuvant Treatment ＋Immunotherapy

EXPERIMENTAL

Drug: Camrelizumab ＋Immunotherapy

Total Neoadjuvant Treatment

NO INTERVENTION

Interventions

Camrelizumab ＋Immunotherapy DRUG

Camrelizumab was used in preoperative treatment.

Total Neoadjuvant Treatment ＋Immunotherapy

Eligibility Criteria

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

You may qualify if:

• \>18，\<75 years old
• ECOG score 0-1
• colorectal adenocarcinoma confirmed by pathology
• 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
• The initial local MRI stage was T4b, or mrN2, or positive MRF, or positive EMVI, or lateral lymph node metastasis (mrLLND+)
• No evidence of distant metastasis
• No history of pelvic radiotherapy
• No history of rectal cancer surgery or chemotherapy
• Systemic infections that do not require antibiotic treatment
• Not associated with immune system diseases
• Blood routine: ANC\>1.5 cells/mm3, HGB\>9.0g /dL, PLT\>800,000/mm3
• Blood biochemistry: total bilirubin ≤1.5xULN, AST≤2.5xULN, ALT≤2.5xULN;
• Serum creatinine ≤1.5 times the upper limit of normal and endogenous creatinine clearance ≥50mL/min (Cockcroft-Gault formula)
• Patients with well-controlled hypertension were allowed to be enrolled
• 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)

You may not qualify if:

• Recurrent rectal cancer
• Microsatellite instability (MSI) or mismatch repair gene deletion (dMMR)
• The patient has had other malignancies in the past 5 years (in addition to properly treated basal cell carcinoma and skin squamous cell carcinoma)
• The patient has had arterial embolic diseases in the past 6 months, such as angina pectoris, MI, TIA, CVA, etc.
• Have received other types of anti-tumor or experimental therapy
• The patient is a pregnant or lactating woman
• The patient has other diseases or mental disorders that may affect the patient's participation in this study
• Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy or VEGFR TKI therapy.
• 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.
• 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.
• Known allergy to the investigational drug and its components
• Active lung disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or a history of active tuberculosis.
• 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.;
• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Beijing Nanjiao Cancer Hospital: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

WU AI WEN, M.D.

CONTACT

+8613911577190; wuaw@sina.com

DONG QIU SHI

CONTACT

+8618600172425; dongqiushi1024@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastrointestinal Center Unit III

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 29, 2024
• Study Start: March 29, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2029
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)