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Neoadjuvant FOLFOXIRI chemotherapy with or without camrelizumab in the treatment of locally advanced rectal cancer: a retrospective cohort study

Neoadjuvant FOLFOXIRI chemotherapy with or without camrelizumab in the treatment of locally advanced rectal cancer: a retrospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114600
Enrollment
Unknown
Registered
2025-12-15
Start date
2025-12-16
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced colorectal cancer

Interventions

camrelizumab groups:None
Chemotherapy Group:None Oxaliplatin: 85 mg/m2, intravenous infusion over 2 hours, day 1. Calcium folinate (Leucovorin): 400 mg/m2, intravenous infusion over 2 hours, day 1. 5-Fluorouracil: 2600–280

Sponsors

Harbin medical university cancer hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 75 years; 2.Clinically diagnosed rectal adenocarcinoma; 3.MRI-assessed stage II (T3-4N0M0) or stage III (T1-4N1-2M0) rectal cancer patients, with the distal margin located <12 cm from the anal verge, and without peritoneal metastasis or other distant metastases; 4.ECOG PS 0-1; 5.Treatment-naïve patients who have not previously received systemic chemotherapy, radiotherapy, local resection, or immune checkpoint inhibitor therapy for colorectal cancer, and have subsequently undergone at least 3 cycles of neoadjuvant therapy with either the FOLFOXIRI chemotherapy regimen or the FOLFOXIRI chemotherapy regimen combined with camrelizumab; 6.Good treatment compliance and no severe diseases in other vital organs; 7.Complete clinical data and follow-up information, with regular clinical follow-up examinations.

Exclusion criteria

Exclusion criteria: 1.Patients with active, suspected, or known autoimmune diseases were excluded; 2.Patients with a history of or concurrent other malignancies (excluding appropriately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma) were excluded; 3.Patients with incomplete treatment records or follow-up data were excluded.

Design outcomes

Primary

MeasureTime frame
Pathological Complete Response ;

Secondary

MeasureTime frame
Neoadjuvant Rectal Cancer Score;Objective Response Rate (ORR);Clinical Complete Response;Consolidated Tumor Complete Response;R0 Resection Rate;Percentage of Tumor Regression;Tumor Regression Grade;Event-Free Survival;Overall Survival;Sphincter Preservation Rate;safety;

Countries

China

Contacts

Public ContactCuibinbin

Harbin medical university cancer hospital

cuibinbin@hrbmu.edu.cn+86 133 5111 2888

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026