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Rectal NeoplasmsPhase 3NCT06017583

Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer

A Phase 3 study testing Tislelizumab, Capecitabine and Oxaliplatin in people with Rectal Neoplasms, run by Yong Zhang,MD 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study aims to evaluate the efficacy and safety of tislelizumab combined with simultaneous integrated boost intensity-modulated radiotherapy in treating locally advanced rectal cancer. To explore a new PD-1 inhibitor adjuvant chemotherapy model combined with radiotherapy to treat locally advanced rectal cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Rectal Neoplasms
What is being tested?
Tislelizumab, Capecitabine and Oxaliplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteChina
Study dates
1 Sep 2023to 31 Aug 2026
Phase
Phase 3
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 70 years.
  • The pathological type of rectal cancer diagnosed by histopathology is adenocarcinoma.
  • Patients with T3-4 in the eighth AJCC stage or positive regional lymph node and no distant metastasis.
  • Having at least one measurable lesion according to RECIST 1.1.
  • ECOG score 0-1.
  • Expected survival time ≥6 months.
  • Major organ function is normal, that is, meeting the following criteria: blood routine: HB≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L; Biochemical examination of ALB≥30g/L, TBIL≤1.5 ULN, ALT and AST≤2.5 ULN, plasma Cr≤1.5 ULN or creatinine clearance ≥60 ml/min.
  • Subjects volunteered to join the study, signed the informed consent, had good compliance, and cooperated with follow-up.

Who cannot join

  • Patients have had or currently have other malignant tumors within 5 years.
  • Patients allergic or sensitive to any drug in the study protocol.
  • Patients innate or acquired immune deficiency (e.g. HIV infection).
  • The presence of any active, known or suspected autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); The subject had vitiligo. Subjects with asthma require bronchodilators for medical intervention.
  • The presence of active infections requiring systemic treatment.
  • The subject has previously received other PD-1 or PD-L1, or CTLA-4 antibody therapy, or other drug therapy targeting immunoregulatory receptor preparations.
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  • Unrelieved toxic effects above CTCAE grade 1 due to any previous treatment, excluding alopecia.
  • Patients with a history of myocardial infarction or stroke, unstable angina pectoris, decompensated heart failure or deep vein thrombosis.
  • Patients with long-term untreated wounds or fractures, major surgical operations or severe traumatic injuries, fractures or ulcers within 4 weeks.
  • Pregnant or lactating women.
  • Patients with liver and kidney dysfunction.
  • Patients with a history of abuse of psychotropic drugs and unable to abstain or patients with mental disorders.
  • Patients who have participated in clinical trials of other drugs within 4 weeks.
  • Patients with concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or affect the patient's completion of the study.
  • The investigator judged that participation in this study was not conducive to the maximum benefit of the subjects.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Yong Zhang, PhD, 13607884001, zhangyonggx@163.com

    Shanshan Ma, PhD, 13557994302, mashanshan@gxmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With Simultaneous Integrated Boost Intensity-modulated Radiotherapy in the Treatment of Locally Advanced Rectal Cancer

This study aims to evaluate the efficacy and safety of tislelizumab combined with simultaneous integrated boost intensity-modulated radiotherapy in treating locally advanced rectal cancer. To explore a new PD-1 inhibitor adjuvant chemotherapy model combined with radiotherapy to treat locally advanced rectal cancer.

Read the detailed description

This is a randomized controlled trial (RCT). Patients with T3-4 in the 8th AJCC stage or positive regional lymph nodes and no distant metastases will be enrolled. Forty-eight patients will be enrolled by inclusion and exclusion criteria. The enrolled patients will be randomly divided into experimental and control groups (twenty-four patients for each group) to receive preoperative neoadjuvant therapy. The experimental group will receive concurrent simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) and concurrent capecitabine chemotherapy, and complete 2 ~ 4 cycles of XELOX chemotherapy, while receiving complete tislelizumab treatment for at least 4 cycles (21 days per cycle). The control group received intensity-modulated radiotherapy (IMRT) without tirellizumab, and the other treatment regiments were consistent with the experimental group. The tumor size will be measured in MRI or CT images, and side effects will be recorded. The primary outcome was CR rate (pathological complete response rate and clinical complete response rate), and secondary outcomes were side effects and 3-year OS and DFS.

Being tested
Tislelizumab, Capecitabine, Oxaliplatin, SIB-IMRT, IMRT
Keywords
Rectal cancer, Tislelizumab, SIB IMRT
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • TislelizumabDrug

    Tirellizumab was administered intravenously at 200mg/d1, 21 days per cycle, with at least 4 cycles completed.

  • CapecitabineDrug

    Oral capecitabine 825mg/m2 bid, radiotherapy day concurrent chemotherapy. Chemotherapy regimen after radiotherapy: XELOX regimen: oxaliplatin intravenous infusion of 130mg/m2/d1+ oral capecitabine 1000mg/m2 bid/ d1-14, 21 days per cycle, at least 2 cycles completed.

  • OxaliplatinDrug

    Chemotherapy regimen after radiotherapy: XELOX regimen: oxaliplatin intravenous infusion of 130mg/m2/d1+ oral capecitabine 1000mg/m2 bid/ d1-14, 21 days per cycle, at least 2 cycles completed.

  • SIB-IMRTRadiation

    The tumor and the related mesenteric region 1cm above and below were simultaneously integrated boost to 5600cGy with the intensity-modulated radiotherapy. The other dose for clinical target volume is 5000 cGy.

  • IMRTRadiation

    The whole dose of the clinical target volume is 5000 cGy with intensity-modulated radiotherapy.

Study groups in NCT06017583
Study groupRoleWhat they receive
Experimental armExperimentalThe experimental group will receive concurrent simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) and concurrent capecitabine chemotherapy, and complete 2 ~ 4 cycles of XELOX chemotherapy, while receiving full tislelizumab treatment for at least 4 cycles (21 days per cycle).
Receives: Drug: Tislelizumab; Drug: Capecitabine; Drug: Oxaliplatin; Radiation: SIB-IMRT
Control armPlacebo comparatorThe control group received intensity-modulated radiotherapy (IMRT) without tirellizumab, and the other treatment regiments were consistent with the experimental group.
Receives: Drug: Capecitabine; Drug: Oxaliplatin; Radiation: IMRT

What is being measured

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

  1. Complete response rate

    Include in pathological complete response rate and clinical complete response rate. MRI/CT will be used for evaluating the carcinoma status. Pathological complete response rate will be evaluated by surgery.

    Measured: 12 weeks~18 weeks

Secondary outcomes (3)

  1. Side effects

    Myelosuppression, radiation enteritis, radiothermitis

    Measured: 6monthes, 3years

  2. Overall survival

    OS was calculated from the date of entry into the study to the date of death or the last follow-up visit.

    Measured: 3 years

  3. Disease free survival

    DFS was calculated from the date of entry into the study to the date of the time from the beginning of randomization to the disease recurrence or progression or death from any cause.

    Measured: 3 years

Timeline

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

  1. First posted30 Aug 2023
  2. Study start1 Sep 2023
  3. Primary completion31 Aug 2024 (estimated)
  4. Study completion31 Aug 2026 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The random number table method.
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06017583
Sponsor's protocol ID
2023-S845-01
Status last verified
Oct 2023
First submitted
18 Aug 2023
Last updated
11 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tislelizumab, Capecitabine and Oxaliplatin in people with Rectal Neoplasms, run by Yong Zhang,MD 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 8 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 Oct 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Complete response rate (time frame: 12 weeks~18 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 NCT06017583.

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 Oct 2023.

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