NCT06787183

Brief Summary

To enhance the treatment efficacy of rectal cancer liver metastasis through a multidisciplinary approach of radiotherapy, immunotherapy, and chemotherapy, and to provide a new direction for the combination treatment strategy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
44mo left

Started Dec 2025

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
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 Progress11%
Dec 2025Dec 2029

First Submitted

Initial submission to the registry

January 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

March 3, 2026

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

January 16, 2025

Last Update Submit

February 28, 2026

Conditions

Locally Advanced Rectal Cancer With Liver Metastases

Keywords

short course radiotheraphyCAPOXQL1706 (bifunctional PD1/CTLA4 dual blocker)

Outcome Measures

Primary Outcomes (1)

  • Progression-free-Survival

    from enlrollment to 36month

Secondary Outcomes (3)

  • Toxic reaction rate above 3rd degree

    from enlrollment to 36month

  • relapse-free survival

    from enlrollment to 36month

  • overall survival

    from enlrollment to 36month

Study Arms (1)

Short course radiotherapy combined with CAPOX and QL1706

EXPERIMENTAL

Two cycles of CAPOX combined with QL1706 were followed by a short course of radiotherapy (CTV 25Gy/5f) and finally two cycles of CAPOX and QL1706.

Radiation: Short course radiotherapyDrug: CapecitabineDrug: OxaliplatinDrug: QL1706

Interventions

Short course radiotherapyRADIATION

CTV 25Gy/5Fx.

Short course radiotherapy combined with CAPOX and QL1706
CapecitabineDRUG

1000mg/m2, d1-14，bid, q3w, 2 cycles.

Short course radiotherapy combined with CAPOX and QL1706
OxaliplatinDRUG

130mg/m2, d1, q3w, 2 cycles

Short course radiotherapy combined with CAPOX and QL1706
QL1706DRUG

5.0 mg/kg, q3w

Short course radiotherapy combined with CAPOX and QL1706

Eligibility Criteria

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

You may qualify if:

  • Age 18-75 years, any gender.
  • Pathologically confirmed rectal cancer with liver metastases (stage M1).
  • Karnofsky Performance Status ≥70.
  • Adequate organ function, no contraindications to radiotherapy, or immunotherapy.
  • Microsatellite/mismatch repair status MSS/pMMR.
  • No prior immunotherapy.
  • Ability to comply with the study protocol during the study period.
  • Signed written informed consent.

You may not qualify if:

  • Pregnant or lactating women.
  • Pathological diagnosis of signet ring cell carcinoma.
  • History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
  • Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
  • Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
  • Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
  • Patients with autoimmune diseases.
  • Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
  • Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; serum albumin ≥30g/L.
  • Known deficiency of dihydropyrimidine dehydrogenase (DPD).
  • Allergy to any investigational drug components.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fuzhou First General Hospital

Fuzhou, Fujian, 350004, China

NOT YET RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

MeSH Terms

Interventions

CapecitabineOxaliplatin

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic Chemicals

Central Study Contacts

Hui Li, MD

CONTACT

+8613600855801lihui70105@126.com

Jinluan Li, MD

CONTACT

+86 15159628678lijinluan@fjmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 22, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2029

Last Updated

March 3, 2026

Record last verified: 2025-07

Locations

CN(2)