A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant Therapy in Locally Advanced Low pMMR/MSS Rectal Cancer

ConditionLocally Advanced Rectal Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorChinese PLA General Hospital

About this trial

In pMMR/MSS locally advanced rectal cancer, can the innovative "chemo-immunotherapy induction + LCRT + chemo-immunotherapy consolidation" approach significantly improve the complete response rate and create opportunities for organ preservation?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-75 years, male or female;

Disqualifiers

Prior or current receipt of any anti-tumor therapy for cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.

Trial design

Design model

Single group

Treatments tested in this trial

Camrelizumab
Drug
patients first receive 2 cycles of camrelizumab combined with CAPOX (capecitabine 1000 mg/m² orally twice daily on days 1-14; oxaliplatin 130 mg/m² intravenously every 3 weeks). This is followed by long-course chemoradiotherapy (LCRT): a total dose of 50.4 Gy delivered in 28 fractions, with concurrent capecitabine 825 mg/m² orally twice daily.

Treatment groups

44 Participants

are divided into 1 treatment group

Group A: experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

CR rate

pCR+cCR

Time frame

cCR is assessed at 4-6 weeks post-therapy by imaging/endoscopy; pCR is assessed postoperatively (surgery at 4-6 weeks post-therapy + pathology within 1-2 weeks after surgery).

Sponsors and contacts

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

Chinese PLA General Hospital

Lead sponsor

Source ClinicalTrials.gov

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