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CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab as First-line Treatment for RAS-Mutant/MSS Metastatic Rectal Cancer

ConditionRectal Neoplasms Malignant
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University Cancer Hospital & Institute

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iparomlimab and Tuvonralimab

    Drug

    (Experimental group) PD-1/CTLA-4 Antibody

  • Radiotherapy to the primary site

    Radiation

    (Experimental group) Radiotherapy to the primary site of rectal

  • Capecitabine

    Drug

    (both groups)

  • Bevacizumab

    Drug

    (both groups)

  • Oxaliplatin injection

    Drug

    (both groups)

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 5 interventions
Group B: Control groupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

12-month disease-free survival rate (progression-free survival rate, PFSR)

Time frame
From randomization to disease progression or death from any cause, whichever occurs first; the progression-free survival rate will be estimated at 12 months.

Secondary outcomes

1

Objective response rate (ORR)

Time frame
From randomization to the first documented tumor response, assessed during the entire treatment period and follow-up, up to 24 months.
2

Disease control rate (DCR)

Time frame
From randomization to the first documented tumor response, assessed during the entire treatment period and follow-up, up to 24 months.
3

Time to response (TTR)

Time frame
From randomization to the first documented objective response (complete or partial response), assessed up to 24 months.
4

Duration of response (DOR)

Time frame
From the first documented objective response (CR or PR) to disease progression or death from any cause, whichever occurs first, assessed up to 24 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Peking University Cancer Hospital & Institute

Lead sponsor

Hebei Medical University Fourth Hospital

Collaborator

Shanxi Province Cancer Hospital

Collaborator

West China Hospital

Collaborator

Peking Union Medical College Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: