Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
The PICC-3 study is a multicentre, single-arm, phase II trial evaluating toripalimab plus celecoxib in patients with mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) locally advanced colorectal cancer. The trial uses a response-adapted treatment strategy, whereby patients with clinical complete response (cCR) after therapy may enter a non-operative management pathway, while patients without cCR proceed to surgery. Response assessment is based on imaging, endoscopy, biopsy evaluation, and ctDNA analysis.
Eligibility criteria
Qualifiers
Signed informed consent and willingness/compliance with study procedures.
Age ≥18 years.
Histologically confirmed colorectal adenocarcinoma.
ECOG performance status 0-1.
Disqualifiers
Presence of distant metastases (M1) confirmed by CT/MRI or PET-CT (at least covering the chest, abdomen, and pelvis).
Complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery.
Inability to achieve complete resection of the primary colorectal tumor.
History or concurrent active malignancy (except malignancies cured ≥5 years ago or adequately treated carcinoma in situ).
Trial design
Treatments tested in this trial
- Toripalimab plus celecoxib
- Non-operative management
- Curative-intent surgery
Treatment groups
105 Participants
are divided into 1 treatment groupSponsors and collaborators
Sun Yat-sen University
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov