Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine as First Line Treatment in Advanced mCRC

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT06195670
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • CRC
  • Metastatic Colorectal Adenocarcinoma
  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Experimental — DRUG
    SCRT: 5\*5Gy for 5 days, after a one-week rest, with fruquintinib plus sintilimab followed; Fruquintinib: qd po, 4mg/d, 2weeks on/1 week off, q3w; Sintilimab: intravenous infusion, 200mg, on day 1, q3w.
  • Active Comparator — DRUG
    Capecitabine: bid po, 1000mg/m², on days 1-14, q3w; Bevacizumab: intravenous infusion, 7.5mg/kg, on day 1, q3w.

Study Details

The aim of this study is to evaluate the efficacy and safety of short course radiotherapy followed by fruquintinib combined with Sintilimab as the first-line treatment of advanced mCRC compared to bevacizumab combined with capecitabine in patients unfit for intensive therapy.

Key Dates

First listed
Jan 8, 2024
Start date
Jan 31, 2024
Status verified
Dec 2023
Primary completion
Jan 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SCRT + fruquintinib + sintilimab
  • Active Comparator: Bevacizumab + Capecitabine

Primary Outcome Measure

Phase 1b - Objective Response Rate (ORR) [ Time Frame: From randomization until disease progression (up to approximately 3-5 years) ]

Central Contacts

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