Rectal CancerPhase 2NCT05957016
Neoadjuvant CIETAI With Concurrent Chemoradiotherapy in Local Advanced Rectal Cancer
A Phase 2 study testing CIETAI-R in people with Rectal Cancer, run by Third Military Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- CIETAI-R
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2023to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Dong Wang, PH.D., 86-23-68757151, dongwang64@hotmail.com
Dong Wang, PH.D.
About this study
Official title: Neoadjuvant Preoperative Arterial Intervention With Concurrent Chemoradiotherapy in Local Advanced Rectal Cancer
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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- CIETAI-R
- Keywords
- local advanced rectal cancer, PD-1 inhibitor, neoadjuvant
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIETAI-RProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| local advanced rectal cancer | Experimental | local advanced rectal cancer are defined as T3/4NanyM0 or T1-2N+M0 Receives: Procedure: CIETAI-R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR)
Measured: 4 months
Secondary outcomes (2)
disease-free survival (DFS)
Measured: 2 years
overall survival (OS)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start30 Aug 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Wang, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957016
- Sponsor's protocol ID
- CIETAI-R
- Status last verified
- Aug 2023
- First submitted
- 8 Jul 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang W, Qian C, Luo J, Chen C, Feng Y, Dai N, Li X, Xiao H, Yang Y, Li M, Li C, Wang D. First in human intraarterial delivery of tislelizumab for the treatment of pMMR locally advanced rectal cancer: A single-arm, open label, phase II clinical trial. Transl Oncol. 2024 Dec;50:102154. doi: 10.1016/j.tranon.2024.102154. Epub 2024 Oct 13.
PubMed 39405605
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Preoperative Arterial Intervention With Concurrent Chemoradiotherapy in Local Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT05957016
- Acronym / sponsor ID
- CIETAI-R
- Conditions
- Rectal Cancer
- Keywords
- local advanced rectal cancer, PD-1 inhibitor, neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| local advanced rectal cancer | Experimental | Procedure: CIETAI-Rlocal advanced rectal cancer are defined as T3/4NanyM0 or T1-2N+M0 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIETAI-R1. 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 2. phase II: Chemoradiotherapy: IMRT：45Gy/25f/5w+capecitabine 1000，po. Bid d1-14, q3w Tirelizumab)200mg ivggt, d1, q3w | Procedure or surgery | local advanced rectal cancer |
Primary outcome
Pathologic complete response (pCR)
Time frame: 4 months
2 secondary outcomes
disease-free survival (DFS)
Time frame: 2 years
overall survival (OS)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Derived from this study: PubMed 39405605Yang W, Qian C, Luo J, Chen C, Feng Y, Dai N, Li X, Xiao H, Yang Y, Li M, Li C, Wang D. First in human intraarterial delivery of tislelizumab for the treatment of pMMR locally advanced rectal cancer: A single-arm, open label, phase II clinical trial. Transl Oncol. 2024 Dec;50:102154. doi: 10.1016/j.tranon.2024.102154. Epub 2024 Oct 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daping Hospital, Third Military Medical University
Chongqing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CIETAI-R in people with Rectal Cancer, run by Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (pCR) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05957016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.