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Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer

ConditionLocally Advanced Rectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital

About this trial

To explore the complete response (CR) rate of modified short-course radiotherapy plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years, any gender.

Pathologically confirmed rectal adenocarcinoma.

Baseline MR stage T3-4/N+.

Distance from anal verge ≤12cm.

Disqualifiers

Pregnant or lactating women.

Pathological diagnosis of signet ring cell carcinoma.

History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.

Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Modified Short-course radiotherapy

    Radiation

    Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.

  • Long-course radiotherapy

    Radiation

    Rectal lesion + metastatic lymph nodes+pelvic lymphatic drainage area,50.4 Gy/25 f

  • Oxaliplatin

    Drug

    130 mg/m²,d1, q3w ,4 cycles

  • Capecitabine

    Drug

    1000 mg/m, d1-14,bid,q3w, 4 cycles

  • Tislelizumab

    Drug

    200mg,d1,q3w,4 cycles

  • Capecitabine

    Drug

    825 mg/m² ,BID ,on radiation days

  • Tislelizumab

    Drug

    200mg,d1,q3w,3 cycles

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Modified Short-course radiotherapy Combined with CAPOX plus TislelizumabExperimental treatment 4 interventions
Group B: Long-course radiotherapy Combined with Capecitabine and TislelizumabActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Complete Response (CR) Rate

Including pCR and CCR.

Time frame
t 3 months after completion of neoadjuvant therapy and up to 12 months after enrollment.

Secondary outcomes

1

Organ Preservation Rate

Sphincter-saving rate in enrolled patients

Time frame
1 year.
2

Surgical Complications

Incidence and severity of postoperative complications.

Time frame
Within 30 days post-surgery
3

the Quality of Life

EORTC Core Quality of Life questionnaire (QLQ-C30)#range from 0-100, with comprehensive assessment indicators, including positive and negative indicators.

Time frame
Baseline, before surgery, and up to 12 months after surgery
4

Grade ≥3 Adverse Event Rate

Incidence of grade 3 or higher adverse events graded according to CTCAE v4.0.

Time frame
From start of treatment to 30 days after last dose, up to approximately 6 months

Other outcomes

Sponsors and contacts

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

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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