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NCT07005570

Short-course Radiotherapy Followed by Sequential Chemotherapy With or Without PD-1 Monoclonal Antibody and Bevacizumab as Total Neoadjuvant Therapy in pMMR/MSS Locally Advanced Rectal Cancer （SPARK）

StatusRecruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 4 years 5 months later, primary endpoint(s) modified.

See at-risk trials from Dechang Diao

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Dec 31, 2031 Show 4 more changesShow less
    • Primary endpoint(s) modified
    • Eligibility criteria expanded, about 28 words
    • Start date: May 1, 2025 to May 23, 2025
    • Secondary endpoints expanded, about 41 words
  2. Enrollment target: 84 to 86v2
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Complete Response Rate
Timeframe: cCR will be assessed 2-4 weeks after completion of TNT, with final clinical classification by 8 weeks after completion of TNT. pCR will be assessed 1 week after TME.

Secondary (10)

Pathological complete response rate
Clinical complete response rate
Tumour regression grade
R0 resection rate
Sphincter preservation rate
Show 5 moreShow less
Event-free survival
Title: Overall survival
3-year cumulative incidence of postoperative local recurrence
3-year cumulative incidence of distant metastasis
Incidence and severity of adverse events

Arms and interventions

Control groupActive comparator

Short-course radiotherapy → CAPOX regimen chemotherapy (6 cycles) → undergo surgery or watch-and-wait strategy within 2-4 weeks after the last dose of capecitabine.

Experimental groupExperimental

Short-course radiotherapy → PD-1 monoclonal antibody and bevacizumab combined with CAPOX regimen chemotherapy (4 cycles) → PD-1 monoclonal antibody combined with CAPOX regimen chemotherapy (2 cycles) → undergo surgery or watch-and-wait strategy within 2-4 weeks after the last dose of capecitabine.

Other: Short-course radiotherapy followed by sequential chemotherapy combined with PD-1 monoclonal antibody and bevacizumab, Short-course radiotherapy followed by sequential chemotherapy

Sites

1 site in 1 country

  • Sixth Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, Guangdong, China