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Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer

ConditionsColorectal CancerMicrosatellite Instability HighMismatch Repair Deficiency
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Toripalimab plus celecoxib

    Drug

    Toripalimab is administered intravenously at 3 mg/kg over 30 minutes once every 2 weeks for a total of 12 doses. Celecoxib is administered orally at 200 mg twice daily for 6 months.

  • Non-operative management

    Procedure/Surgery

    Patients achieving clinical complete response (cCR) according to comprehensive response assessment, including imaging, endoscopy, digital rectal examination (if applicable), and ctDNA evaluation, may undergo non-operative management.

  • Curative-intent surgery

    Procedure/Surgery

    Patients who do not achieve cCR will undergo curative-intent surgery.

Treatment groups

105 Participants
are divided into 1 treatment group
Group A: Toripalimab plus celecoxibExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Event-free survival (EFS)

the time from the first dose of study treatment to the occurrence of one of the following events: locally progressive disease of the primary tumour precluding curative-intent surgery, R2 resection, local recurrence after R0 or R1 resection, unsalvageable local regrowth during non-operative management, distant metastasis, a second primary colorectal cancer, or death from any cause, whichever occurs first.

Time frame
3 years

Secondary outcomes

1

Pathological complete response (pCR) rate

the percentage of subjects with no residual viable tumor in the resected primary tumor specimen and all sampled regional lymph nodes after radical surgery (ypT0N0).

Time frame
3 years
2

Clinical complete response (cCR) rate

the percentage of subjects achieving no evidence of residual tumour on comprehensive response assessment, including imaging, endoscopy with negative biopsy findings, digital rectal examination (if applicable), and ctDNA evaluation.

Time frame
3 years
3

Complete response (CR) rate

the percentage of subjects achieving pathological complete response (pCR) after surgery or clinical complete response (cCR) with non-operative management.

Time frame
3 years
4

Overall survival (OS)

the time from the first dose of study treatment to death from any cause.

Time frame
5 years

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Sponsor institution

Source ClinicalTrials.gov
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