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Radiotherapy Plus CAPOX, and Iparomlimab and Tuvonralimab (QL1706) as Neoadjuvant Therapy for LARC

NCT07291401 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-12-18

No results posted yet for this study

Summary

This study is a single-center, prospective, randomized, double-arm, Phase II clinical trial designed to evaluate the efficacy of radiotherapy combined with CAPOX, and Iparomlimab and Tuvonralimab (QL1706) as neoadjuvant therapy for locally advanced rectal cancer. Additionally, the study seeks to explore the relationship between biomarkers in blood and tumor tissue and treatment efficacy.

Eligible participants (locally advanced rectal cancer) were randomly assigned in a 1:1 ratio to two groups.

Participants will:

Group A patients received radiotherapy, chemotherapy, and immunotherapy. During the first week of radiotherapy, they received one cycle of CAPOX concurrent chemoradiotherapy. Two weeks after the completion of radiotherapy, they continued with four cycles of CAPOX combined with QL1706 immunotherapy.

Group B patients received radiotherapy and chemotherapy. After completing the concurrent radiotherapy and chemotherapy, they rested for 2-3 weeks before completing 3 cycles of CAPOX consolidation chemotherapy.

Two to three weeks after the completion of neoadjuvant therapy in groups A and B, the efficacy was evaluated, and a decision was made on whether to proceed with surgery or watchful waiting based on the efficacy.

Conditions

  • Rectal Cancer Patients

Interventions

COMBINATION_PRODUCT

lparomlimab and Tuvonralimab Injection and CPAOX and radiotherapy

Neoadjuvant chemoradiotherapy + immunotherapy: Pelvic radiotherapy (IMRT), 36 Gy/12 fractions/3 weeks; adaptive radiotherapy booster of 5-6 Gy/2 fractions is permitted for residual lesions. During the first week of radiotherapy, one cycle of CAPOX regimen concurrent chemoradiotherapy is administered (oxaliplatin, 100 mg/m2, D1, IV drip; capecitabine, 850 mg/m2, BID, oral on the day of radiotherapy). Two weeks after radiotherapy, four cycles of IT-CAPOX regimen immunotherapy combined with chemotherapy are continued (epaloliposide (QL1706) 5 mg/kg, D1, IV drip; oxaliplatin, 130 mg/m2, D1, IV drip; capecitabine, 1000 mg/m2, BID, PO, D1-14, Q3W). Two to three weeks after the completion of immunotherapy and chemotherapy, a comprehensive follow-up evaluation of efficacy is conducted, and surgical treatment is planned.

COMBINATION_PRODUCT

CPAOX and radiotherapy

Neoadjuvant concurrent chemoradiotherapy: Pelvic radiotherapy, IMRT 45-50.4 Gy/25-28 F, for a total of 5-6 weeks. During radiotherapy, administer oral capecitabine concurrent chemoradiotherapy (capecitabine, 850 mg/m2, BID, orally on the day of radiotherapy). After radiotherapy, rest for 2-3 weeks, then complete 3 cycles of CAPOX consolidation chemotherapy (oxaliplatin, 130 mg/m2, D1, IV drip; capecitabine, 1000 mg/m2, BID, PO, D1-14, Q3W). 2-3 weeks after the completion of consolidation chemotherapy, conduct a comprehensive follow-up assessment of the efficacy, and surgical treatment is planned.

Sponsors & Collaborators

  • Zhongnan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-01-01
Completion
2029-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07291401 on ClinicalTrials.gov