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Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients

ConditionsColorectal CancerLiver Metastases
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases (RAS/BRAF wild-type, pMMR/MSS) compared to FOLFOX alone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 and ≤75 years old

Histologically confirmed colorectal adenocarcinoma

Radiological and/or pathological confirmation of liver metastases, with ≤5 lesions

Genetic testing and/or immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR/MSS

Disqualifiers

Diagnosis of colorectal cancer with distant extrahepatic metastases

Prior chemotherapy, targeted therapy, intervention, or immunotherapy for liver metastases

No planned surgical resection for liver metastatic lesions

Received oxaliplatin-containing adjuvant chemotherapy regimen within the past one year

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oxaliplatin

    Drug

    5 mg/m2 IV on day 1

  • Fluorouracil

    Drug

    400 mg/m2 IV bolus on day 1, followed by 2.4 g/m2 continuous IV infusion over 48 hours

  • Serplulimab

    Drug

    200 mg IV infusion on day 1

  • Bevacizumab

    Drug

    5 mg/kg IV infusion on day 1

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: FOLFOX only groupActive comparator 2 interventions
Group B: Serplulimab + Bevacizumab + FOLFOXExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

3-year Progression-Free Survival Rate

The proportion of patients who, following the initiation of treatment, remain both alive and without evidence of disease progression for a consecutive period of three years.

Time frame
Assessed for three years following the initiation of treatment

Secondary outcomes

1

Median Overall Survival

The duration of time from diagnosis until death

Time frame
Assessed throughout the study duration (5 years)
2

Major Pathological Response (MPR)

Defined as residual viable tumor of less than or equal to 10%

Time frame
Assessed following neoadjuvant treatment and resection of CRLM (up to 5 years)
3

Pathologic complete response (pCR)

The absence of tumor cells in all specimens.

Time frame
Assessed following neoadjuvant treatment and resection of CRLM (up to 5 years)
4

Pathological Partial Response

Defined as residual viable tumor of more than 10% but less than 50%

Time frame
Assessed following neoadjuvant treatment and resection of CRLM (up to 5 years)

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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