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Rectal NeoplasmsPhase 2NECINCT05420584

Neoadjuvant Arterial Embolization Chemotherapy Combined PD-1 Inhibitor for Locally Advanced Rectal Cancer

A Phase 2 study testing Arterial chemoembolization, Tislelizumab Injection and XELOX in people with Rectal Neoplasms, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Rectal cancer is one of the common malignant tumors of the digestive tract. Some patients with rectal cancer are already advanced tumors when they are first diagnosed. At this time, the tumor has local infiltration, the probability of recurrence and metastasis after surgical resection is high, and even radical tumor… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rectal Neoplasms
What is being tested?
Arterial chemoembolization, Tislelizumab Injection and XELOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
1 siteChina
Study dates
29 Nov 2022to 31 Oct 2025
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

  • Pathologically confirmed rectal adenocarcinoma (immunohistochemistry, polymerase chain reaction(PCR) or next-generation sequencing(NGS) sequencing methods are acceptable).
  • Magnetic resonance imaging (MRI) measurement of tumor inferior margin ≤12cm from the anus.
  • MRI staging is cT3-4 N0 or cT1-4 N+, no multiple primary cancers or distant metastasis.
  • Life expectancy ≥ 1 year.
  • No anti-tumor therapy, no contraindications to interventional embolization, immunotherapy and chemotherapy.
  • Patients who understand the study protocol and are willing to participate in this study provide written informed consent.

Who cannot join

  • Refuse to participate in this study.
  • Multifocal colorectal cancer.
  • Past history of malignancy, excluding basal cell carcinoma/papillary thyroid carcinoma/various types of carcinoma in situ.
  • Inability to receive chemotherapy, such as but not limited to bone marrow suppression, etc.
  • Major organ diseases (such as but not limited to chronic obstructive pulmonary disease, coronary heart disease and renal insufficiency, etc.) during acute exacerbation and or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia and myocarditis, etc.), American Society of Anesthesiologists(ASA) score > 3.
  • Mental disability or illiteracy or language and communication barriers cannot understand the research protocol.
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  • There are contraindications to arterial puncture, such as but not limited to severe arteriosclerosis or even atresia, coagulation dysfunction, long-term use of anticoagulants and cannot be stopped, etc.
  • Obstruction or high risk of obstruction by rectal tumor and/or bleeding and/or perforation.
  • Peripheral sensory nerve disorder, unable to receive oxaliplatin-based chemotherapy.
  • Lateral pelvic lymph node metastasis (mainly supplied by the internal iliac artery).
  • Pregnancy or breastfeeding.
  • Contraindications for MRI。
  • Consecutive use of corticosteroids for more than 3 days within 1 month before signing the consent form。
  • MRI assessment was T4b or MRF positive。
  • Other scenarios deemed inappropriate by the investigators for this study.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine

    Yiwu, Zhejiang, 322000

    Yiqun Fan, +86-579-89935997, 632921213@qq.com

    Recruiting

Other trials in China

About this study

Official title: Phase Ⅱ Clinical Trial of Neoadjuvant Arterial Embolization Chemotherapy Combined Immune Checkpoint Inhibitor for Locally Advanced Rectal Cancer: A Single Arm Prospective Sturdy

Rectal cancer is one of the common malignant tumors of the digestive tract. Some patients with rectal cancer are already advanced tumors when they are first diagnosed. At this time, the tumor has local infiltration, the probability of recurrence and metastasis after surgical resection is high, and even radical tumor resection cannot be performed. Neoadjuvant chemotherapy and radiotherapy have become one of the important treatment methods for these patients to increase the rate of radical tumor resection. However, a series of side effects of neoadjuvant radiotherapy can even continue after the end of radiotherapy, and even increase the incidence of postoperative complications. Superselective arterial interventional chemotherapy has been widely used in preoperative neoadjuvant chemotherapy for various tumors, and its efficacy in rectal cancer has also been confirmed. In addition, as a hot spot in tumor treatment, tumor immunotherapy has shown exciting effects in the NICHE study of neoadjuvant immunotherapy before colon cancer surgery. Moreover, Oxaliplatin is a classic chemotherapeutic drug that induces Immunogenic cell death effects, which induce antitumor immunity.

Therefore, in order to optimize the preoperative neoadjuvant therapy plan, the investigators propose a treatment method of superselective arterial chemoembolization combined with immunotherapy and systemic chemotherapy, in order to obtain better preoperative conversion therapy effect and reduce the adverse reactions of neoadjuvant therapy.

Being tested
Arterial chemoembolization, Tislelizumab Injection, XELOX, Pelvic MRI, Laparoscopic radical resection of rectal cancer
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arterial chemoembolizationProcedure or surgery

    The blood supplying artery of the tumor is selected for drug injection with Oxaliplatin 85mg/m2 combined Raltitrexed 3mg/m2. After drug injection, gelatin sponge is used for embolization.

  • Tislelizumab InjectionDrug

    Tislelizumab Injection 200mg i.v. q3w, A total of 3 cycles are administered.

  • XELOXDrug

    Capecitabine 1,000 mg/m2 bid, po, on days 1-14 Oxaliplatin: 130 mg/m2, i.v. day 1 Cycles are repeated on day 22. A total of 3 cycles are administered.

  • Pelvic MRIDiagnostic test

    Pelvic MRI to evaluate efficacy

  • Laparoscopic radical resection of rectal cancerProcedure or surgery

    Surgical treatment for patients who meet the surgical conditions

Study groups in NCT05420584
Study groupRoleWhat they receive
experimental armExperimentalNot described
Receives: Procedure: Arterial chemoembolization; Drug: Tislelizumab Injection; Drug: XELOX; Diagnostic Test: Pelvic MRI; Procedure: Laparoscopic radical resection of rectal cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Imaging Tumor Regression Rate

    Tumor regression on imaging after neoadjuvant therapy

    Measured: From date of the start of drugs treatment until the end of drugs treatment (nearly 3 weeks)

Secondary outcomes (4)

  1. Pathologic Complete Response

    There is no histological evidence of malignancy in the primary tumor and metastatic regional lymph nodes, or there is only a carcinoma in situ component

    Measured: From date of the start of drugs treatment until the operation is completed (nearly 4 weeks)

  2. Disease Free Survival

    Time from postoperative disease-free survival to disease recurrence or metastasis

    Measured: 36 months

  3. Safety (The side effects)

    The side effects of this study

    Measured: 36 months

  4. Pathological Tumor Regression Rate

    Tumor regression on pathology after neoadjuvant therapy

    Measured: From date of the start of drugs treatment until the end of drugs treatment (nearly 3 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2022
  2. Study start29 Nov 2022
  3. Primary completion30 Nov 2024 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Resources

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
83 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05420584
Sponsor's protocol ID
K2022129
Acronym
NECI
Status last verified
May 2023
First submitted
12 Jun 2022
Last updated
11 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Patel UB, Taylor F, Blomqvist L, George C, Evans H, Tekkis P, Quirke P, Sebag-Montefiore D, Moran B, Heald R, Guthrie A, Bees N, Swift I, Pennert K, Brown G. Magnetic resonance imaging-detected tumor response for locally advanced rectal cancer predicts survival outcomes: MERCURY experience. J Clin Oncol. 2011 Oct 1;29(28):3753-60. doi: 10.1200/JCO.2011.34.9068. Epub 2011 Aug 29.

    PubMed 21876084

  • Chalabi M, Fanchi LF, Dijkstra KK, Van den Berg JG, Aalbers AG, Sikorska K, Lopez-Yurda M, Grootscholten C, Beets GL, Snaebjornsson P, Maas M, Mertz M, Veninga V, Bounova G, Broeks A, Beets-Tan RG, de Wijkerslooth TR, van Lent AU, Marsman HA, Nuijten E, Kok NF, Kuiper M, Verbeek WH, Kok M, Van Leerdam ME, Schumacher TN, Voest EE, Haanen JB. Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers. Nat Med. 2020 Apr;26(4):566-576. doi: 10.1038/s41591-020-0805-8. Epub 2020 Apr 6.

    PubMed 32251400

  • Fan Y, Zhu X, Xu C, Ding C, Hu J, Hong Q, Wang J. Neoadjuvant Arterial Embolization Chemotherapy Combined PD-1 Inhibitor for Locally Advanced Rectal Cancer (NECI Study): a protocol for a phase II study. BMJ Open. 2023 Mar 13;13(3):e069401. doi: 10.1136/bmjopen-2022-069401.

    PubMed 36914193

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Arterial chemoembolization, Tislelizumab Injection and XELOX in people with Rectal Neoplasms, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine 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 6 inclusion and 15 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 11 May 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?

Imaging Tumor Regression Rate (time frame: From date of the start of drugs treatment until the end of drugs treatment (nearly 3 weeks)). 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 NCT05420584, which also lists 3 linked publications.

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 11 May 2023.

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