CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab… (NCT07383285) | Clinical Trial Compass
Not Yet RecruitingPhase 2
CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab as First-line Treatment for RAS-Mutant/MSS Metastatic Rectal Cancer
106 participantsStarted 2026-02-01
Plain-language summary
Research objective: To compare the efficacy and safety of Capox + Bev versus Capox + Bev combined with primary site radiotherapy + (Iparomlimab and Tuvonralimab) as the first-line treatment for RAS Mutation/pMMR metastatic rectal cancer patients.
Study endpoint:
Primary endpoint: 12-month progression-free survival rate (PFSR)
Secondary endpoints:
* The objective response rate (ORR) and disease control rate (DCR) as determined by the investigator according to the RECIST 1.1 standard, time to response (TTR), duration of response (DOR), progression-free survival (PFS), 6-month progression-free survival rate (PFSR), overall survival (OS);
* The frequency and severity of adverse events (AEs) during treatment (NCI CTCAE 5.0).
This study will enroll 106 patients (stratification factors: presence or absence of liver metastasis; whether NED could be achieved). They were randomly assigned in a 1:1 ratio to:
The treatment group: Capox + Bev combined with primary site radiotherapy and (Iparomlimab and Tuvonralimab), administered every 3 weeks (Q3w), up to a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev + (Iparomlimab and Tuvonralimab), administered every 3 weeks (Q3w).
The control group: Capox + Bev, administered every 3 weeks (Q3w), up to a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev, administered every 3 weeks (Q3w).
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The subjects were able to understand the informed consent form, voluntarily participated and signed the informed consent form;
✓. On the day of signing the informed consent form, the subjects were aged between 18 and 75 years old, regardless of gender;
✓. Pathological tissue diagnosis confirmed rectal adenocarcinoma (including signet ring cell carcinoma and mucinous adenocarcinoma);
✓. The lower boundary of the lesion was within 15 cm from the anal verge;
✓. The clinical stage was stage IV;
✓. The genetic test results were KRAS or NRAS mutations, without BRAF V600 mutations, and the immunohistochemical results were pMMR;
✓. The subjects had not received palliative drug treatment, or had received 1 cycle of FOLFOX/CAPOX and had not undergone tumor efficacy assessment;
✓. According to the RECIST 1.1 standard, there was at least 1 measurable lesion or assessable lesion at the baseline;
Timeframe: From randomization to disease progression or death from any cause, whichever occurs first; the progression-free survival rate will be estimated at 12 months.
Trial details
NCT IDNCT07383285
SponsorPeking University Cancer Hospital & Institute
. Active coronary heart disease with angina pectoris or patients who need to take medication to prevent angina attacks;
✕. NYHA II-IV grade chronic heart failure;
✕. Uncontrolled hypertension after drug treatment (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
✕. Major vascular diseases (such as aortic aneurysm, aortic dissection aneurysm, internal carotid artery stenosis);
✕. Has had thromboembolic or cerebrovascular embolic events within 6 months. (3) Have the following digestive system diseases:
✕. Have bleeding (including hemoptysis) or coagulation disorders;
✕. Are taking warfarin, aspirin (except for small doses of less than 100 mg per day), low molecular weight heparin and other antiplatelet aggregation Chinese and Western drugs.