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

ConditionRectal Neoplasms
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorYong Zhang,MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tislelizumab

    Drug

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

  • Capecitabine

    Drug

    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.

  • Oxaliplatin

    Drug

    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-IMRT

    Radiation

    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.

  • IMRT

    Radiation

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

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Experimental armExperimental treatment 4 interventions
Group B: Control armPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame
12 weeks~18 weeks

Secondary outcomes

1

Side effects

Myelosuppression, radiation enteritis, radiothermitis

Time frame
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.

Time frame
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.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yong Zhang,MD

Lead sponsor

First Affiliated Hospital of Guangxi Medical University

Sponsor institution

Source ClinicalTrials.gov
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