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Neoadjuvant CIETAI With Concurrent Chemoradiotherapy in Local Advanced Rectal Cancer

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CIETAI-R
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring local advanced rectal cancer, PD-1 inhibitor, neoadjuvant

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Local advanced Rectal cancer: stage T3/4NanyM0 or T1-2N+M0. Ages: 18 to 75. No previously received chemotherapy drugs and radiation therapy. ECOG score: 0 - 2. Appropriate organ function, as defined below: (Hematology and blood biochemistry examination must be completed within 7 days before the registration date) i) White blood cell count ≥ 4,000/mm3. ii) Neutrophil count ≥ 1,500/mm3. iii) Hemoglobin ≥ 10 g/dL. iv) Platelet count ≥ 100,000/mm3. v) Total bilirubin ≤ 1.5 times the upper limit of normal (ULN). vi. Liver function Index (AST & ALT) ≤ 1.5 times the upper limit of normal (ULN). vii. Serum creatinine ≤1.5 times the upper limit of normal or creatinine clearance ≥60 ml/min. Tolerance of orally administration of capecitabine. Can understand the study, have good compliance, cooperate with follow-up. Exclusion Criteria: Severe allergic reaction to humanized antibodies or fusion proteins; Hypersensitivity to any component contained in contrast agent or granule embolic agent; Diagnosed with an immune deficiency or is receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first administration of the study, allowing the use of physiological doses of glucocorticoids (≤10mg/ day of prednisone or equivalent); Active, known, or suspected autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hypothyroidism, including, but not limited to, these diseases or syndromes). Subjects who have type 1 diabetes, hypothyroidism requiring hormone replacement therapy, skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, or hair loss), or conditions that are not expected to recur in the absence of external triggers may be enrolled; Pre-existing severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina pectoris, myocardial infarction, and severe heart valve disease; Active hepatitis B (HBV DNA ≥ 2000IU/ml or 104copies/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of analysis). Active tuberculosis (TB) infection. Patients with a history of active tuberculosis infection within the previous 1 year should be excluded, even if they have been treated; Patients with a history of active tuberculosis infection more than 1 year ago should also be excluded unless the duration and type of antituberculosis therapy previously used is demonstrated to be appropriate. Brain metastases accompanied by symptoms or symptoms controlled for less than 2 months; Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to enrollment; Pregnant or lactating female patients (women of childbearing age must confirm that the pregnancy test is negative within 7 days before the first administration of the drug, if it is positive, ultrasound examination must be performed to rule out pregnancy), subjects of childbearing age refuse to accept contraceptive measures; Combined with other malignancies, except cured skin basal cell carcinoma or skin squamous cell carcinoma or in situ carcinoma of any other site Patients with any physical signs or history of bleeding, regardless of severity; Non-healing wounds, ulcers, or fractures were present in patients with any bleeding or bleeding events ≥CTCAE grade 3 during the 4 weeks prior to grouping; Arteriovenous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; Dementia, altered mental status or any mental illness that would prevent understanding or giving informed consent or completing the questionnaire Other serious concomitant diseases judged by the investigator.

Sites / Locations

  • Daping Hospital, Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

local advanced rectal cancer

Arm Description

local advanced rectal cancer are defined as T3/4NanyM0 or T1-2N+M0

Outcomes

Primary Outcome Measures

Pathologic complete response (pCR)

Secondary Outcome Measures

disease-free survival (DFS)
overall survival (OS)

Full Information

First Posted
July 8, 2023
Last Updated
August 22, 2023
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05957016
Brief Title
Neoadjuvant CIETAI With Concurrent Chemoradiotherapy in Local Advanced Rectal Cancer
Official Title
Neoadjuvant Preoperative Arterial Intervention With Concurrent Chemoradiotherapy in Local Advanced Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To increase the efficacy of neoadjuvant PD-1/PD-1 checkpoint inhibitor in local advanced rectal cancer (LARC), we propose preoperative arterial infusion of Tirellizumab and oxaliplatin followed by tumor artery embolization with concurrent chemoradiotherapy as neoadjuvant regimen for LARC.
Detailed Description
Based our previous multi-center randomized controlled study (Preoperative arterial perfusion Chemo- embolization combined with radiotherapy for locally advanced rectal cancer, NCT03601156), the idea of "preoperative arterial chemo-immuno-embolization combined with radiotherapy for locally advanced rectal cancer (CIETAI-R)" was proposed. This is also the serial study of CIETAI that explore the efficacy of tumor arterial chemo-immuno-embolization in lung cancer, LARC, metastatic liver cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
local advanced rectal cancer, PD-1 inhibitor, neoadjuvant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
local advanced rectal cancer
Arm Type
Experimental
Arm Description
local advanced rectal cancer are defined as T3/4NanyM0 or T1-2N+M0
Intervention Type
Procedure
Intervention Name(s)
CIETAI-R
Intervention Description
phase I: (1) Chemo-Immulo-embolization via Tumor Arterial, CIETAI: DSA guided tumor artery infusion of oxaliplatin 130 mg/m2+PD-1 inhibitor (Tirelizumab) 200mg, followed by gelatin sponge particles (350-560um) embolization phase II: Chemoradiotherapy: IMRT:45Gy/25f/5w+capecitabine 1000,po. Bid d1-14, q3w Tirelizumab)200mg ivggt, d1, q3w
Primary Outcome Measure Information:
Title
Pathologic complete response (pCR)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
disease-free survival (DFS)
Time Frame
2 years
Title
overall survival (OS)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Local advanced Rectal cancer: stage T3/4NanyM0 or T1-2N+M0. Ages: 18 to 75. No previously received chemotherapy drugs and radiation therapy. ECOG score: 0 - 2. Appropriate organ function, as defined below: (Hematology and blood biochemistry examination must be completed within 7 days before the registration date) i) White blood cell count ≥ 4,000/mm3. ii) Neutrophil count ≥ 1,500/mm3. iii) Hemoglobin ≥ 10 g/dL. iv) Platelet count ≥ 100,000/mm3. v) Total bilirubin ≤ 1.5 times the upper limit of normal (ULN). vi. Liver function Index (AST & ALT) ≤ 1.5 times the upper limit of normal (ULN). vii. Serum creatinine ≤1.5 times the upper limit of normal or creatinine clearance ≥60 ml/min. Tolerance of orally administration of capecitabine. Can understand the study, have good compliance, cooperate with follow-up. Exclusion Criteria: Severe allergic reaction to humanized antibodies or fusion proteins; Hypersensitivity to any component contained in contrast agent or granule embolic agent; Diagnosed with an immune deficiency or is receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first administration of the study, allowing the use of physiological doses of glucocorticoids (≤10mg/ day of prednisone or equivalent); Active, known, or suspected autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hypothyroidism, including, but not limited to, these diseases or syndromes). Subjects who have type 1 diabetes, hypothyroidism requiring hormone replacement therapy, skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, or hair loss), or conditions that are not expected to recur in the absence of external triggers may be enrolled; Pre-existing severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina pectoris, myocardial infarction, and severe heart valve disease; Active hepatitis B (HBV DNA ≥ 2000IU/ml or 104copies/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of analysis). Active tuberculosis (TB) infection. Patients with a history of active tuberculosis infection within the previous 1 year should be excluded, even if they have been treated; Patients with a history of active tuberculosis infection more than 1 year ago should also be excluded unless the duration and type of antituberculosis therapy previously used is demonstrated to be appropriate. Brain metastases accompanied by symptoms or symptoms controlled for less than 2 months; Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to enrollment; Pregnant or lactating female patients (women of childbearing age must confirm that the pregnancy test is negative within 7 days before the first administration of the drug, if it is positive, ultrasound examination must be performed to rule out pregnancy), subjects of childbearing age refuse to accept contraceptive measures; Combined with other malignancies, except cured skin basal cell carcinoma or skin squamous cell carcinoma or in situ carcinoma of any other site Patients with any physical signs or history of bleeding, regardless of severity; Non-healing wounds, ulcers, or fractures were present in patients with any bleeding or bleeding events ≥CTCAE grade 3 during the 4 weeks prior to grouping; Arteriovenous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; Dementia, altered mental status or any mental illness that would prevent understanding or giving informed consent or completing the questionnaire Other serious concomitant diseases judged by the investigator.
Facility Information:
Facility Name
Daping Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Wang, PH.D.
Phone
86-23-68757151
Email
dongwang64@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dong Wang, PH.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Neoadjuvant CIETAI With Concurrent Chemoradiotherapy in Local Advanced Rectal Cancer

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