NCT07446465

Brief Summary

To evaluate the efficacy and safety of immune checkpoint inhibitor-based combination therapy with targeted therapy and chemotherapy in patients with locally advanced unresectable or metastatic colorectal cancer.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
6mo left

Started Mar 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Mar 2026Jan 2027

First Submitted

Initial submission to the registry

February 24, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

February 24, 2026

Last Update Submit

February 28, 2026

Conditions

Colorectal Cancer (Locally Advanced or Metastatic)Colorectal Cancer Microsatellite Stable (MSS)

Outcome Measures

Primary Outcomes (2)

  • Conversion Rate to Surgery

    ≤ 6 months

  • Objective Response Rate

    ≤6 month

Secondary Outcomes (6)

  • Disease Control Rate

    6 months

  • Depth of Response

    6 months

  • Early Tumor Shrinkage

    6 months

  • R0 Resection Rate

    6 months

  • Progression-Free Survival

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Conversion Therapy

EXPERIMENTAL

Conversion Therapy (≤6 months) Fruquintinib: 4 mg orally once daily, Days 1-21, every 4 weeks mFOLFOX6: Oxaliplatin 85 mg/m² IV q2w Leucovorin 400 mg/m² IV q2w 5-FU 400 mg/m² IV bolus Day 1 5-FU 1200 mg/m²/day continuous IV infusion Days 2-3 Serplulimab: 200 mg IV Day 1, q2w Fruquintinib must be stopped ≥2 weeks prior to surgery and resumed ≥4 weeks postoperatively.

Drug: SerplulimabDrug: FruquintinibDrug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Interventions

SerplulimabDRUG

Serplulimab: 200 mg IV Day 1, q2w

Conversion Therapy
FruquintinibDRUG

Fruquintinib: 4 mg orally once daily, Days 1-21, every 4 weeks

Conversion Therapy
mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)DRUG

Oxaliplatin 85 mg/m² IV q2w Leucovorin 400 mg/m² IV q2w 5-FU 400 mg/m² IV bolus Day 1 5-FU 1200 mg/m²/day continuous IV infusion Days 2-3

Conversion Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years;
  • Histologically confirmed adenocarcinoma of colorectal cancer, initially unresectable locally advanced or metastatic/recurrent disease;
  • Expected survival ≥12 weeks;
  • No prior systemic antitumor therapy for colorectal cancer;
  • Confirmed pMMR by IHC or MSS/MSI-L by PCR or NGS;
  • ECOG PS 0-1;
  • At least one measurable lesion per RECIST v1.1;
  • Adequate organ and bone marrow function;
  • Controlled viral hepatitis status as specified;
  • Signed written informed consent.

You may not qualify if:

  • Prior immune checkpoint inhibitor therapy;
  • CNS or leptomeningeal metastases;
  • Uncontrolled cardiovascular disease or hypertension;
  • Active autoimmune disease requiring systemic therapy;
  • Active infection including tuberculosis;
  • Recent major surgery;
  • Pregnancy or lactation;
  • Any condition deemed by investigators to compromise safety or study compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Xuhui, China

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Interventions

HMPL-013OxaliplatinLeucovorinFluorouracil

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Ye Xu

CONTACT

+86 18017312565yexu@shmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 3, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Locations

CN(1)