AK104 Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS CRLM (APSOC)

NCT07544784 | Recruiting Phase 2

• 1 other identifier: 2025-192-4341
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized controlled, single-center phase II clinical study. It aims to compare the efficacy of AK104 plus radiotherapy combined with standard therapy versus standard therapy as first-line treatment for liver metastases from metastatic colorectal cancer.

Conditions

Colorectal Cancer Liver Metastases (CRLM)

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  up to approximately 2 years

Secondary Outcomes (6)

• ETS

  up to approximately 2 years

• PFS

  up to approximately 2 years

• OS

  up to approximately 2 years

• R0 Resection Rate / NED Rate

  up to approximately 2 years

• Safety

  up to approximately 2 years

Other Outcomes (1)

• Biomarker

  up to approximately 2 years

Study Arms (2)

Control group

EXPERIMENTAL

standard therapy

Drug: Standard of therapy

Experimental group

EXPERIMENTAL

AK104 plus radiotherapy combined with standard therapy

Drug: AK104 with radiotherapy; Drug: Standard of therapy

Interventions

AK104 with radiotherapy DRUG

AK104 with radiotherapy combined with standard of therapy

Experimental group

Standard of therapy DRUG

Standard of therapy including target therapy and chemotherapy

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, with no gender restriction;
• Histologically or cytologically confirmed colorectal cancer;
• Presence of liver metastases, with at least one measurable target lesion (per RECIST 1.1 criteria) in addition to a single liver metastatic lesion amenable to radiotherapy; patients with initially resectable colorectal cancer liver metastases are excluded;
• Treatment-naive patients; or patients with postoperative recurrence who have not received any anti-tumor therapy within 6 months and at least 6 months have elapsed since the last adjuvant chemotherapy;
• ECOG performance status score of 0-1;
• Expected overall survival ≥ 3 months;
• Adequate organ function and reserve, meeting the following laboratory criteria within 7 days prior to screening (inclusive):
• HB ≥ 90 g/dL, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L; BIL \< 1.5 × ULN, ALT and AST \< 2.5 × ULN; ALT and AST \< 5 × ULN in the presence of liver metastases; Serum Cr ≤ 1 × ULN, creatinine clearance \> 50 mL/min (calculated using the Cockcroft-Gault formula); International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; for patients on anticoagulant therapy, PT within the intended therapeutic range is acceptable;
• Voluntary participation in the study, provision of signed informed consent, good compliance, and willingness to comply with follow-up procedures.

You may not qualify if:

• History of other malignancy within 3 years prior to enrollment, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
• Symptomatic brain or meningeal metastases, except those treated locally and stable for more than 2 months without symptoms.
• Presence of gastrointestinal obstruction, gastrointestinal bleeding (≥+++ fecal occult blood), or perforation.
• Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, CD137, or CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulatory or checkpoint pathways.
• Subjects with active autoimmune disease or a history of autoimmune disease that may relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or patients at high risk (e.g., organ transplant recipients requiring immunosuppressive therapy).
• However, patients with vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic therapy in the past 2 years, hypothyroidism requiring only thyroid hormone replacement, or type 1 diabetes mellitus requiring only insulin replacement may be enrolled.
• Current interstitial lung disease or pneumonitis, pulmonary fibrosis, acute pulmonary disease, or radiation pneumonitis.
• Participation in another investigational drug study within 4 weeks prior to the first dose (based on receipt of investigational product), unless participation was in an observational (non-interventional) study.
• Use of immunosuppressive medications within 4 weeks prior to the first study treatment, excluding topical, nasal, inhaled, or other local corticosteroids; physiological doses of systemic corticosteroids (i.e., ≤10 mg/day prednisone or equivalent); or short-term (≤7 days) corticosteroids for prophylaxis or treatment of non-autoimmune allergic conditions.
• Administration of a live attenuated vaccine within 4 weeks prior to the first dose or planned administration during the study period.
• Note: Administration of inactivated seasonal influenza vaccine by injection within 4 weeks prior to the first dose is permitted; live attenuated influenza vaccines are not permitted.
• Major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first study treatment, or expectation of requiring major non-study surgery during the study period.
• History of human immunodeficiency virus (HIV) infection (i.e., positive HIV antibody), other acquired or congenital immunodeficiency disorders, organ transplantation, or stem cell transplantation.
• Active chronic hepatitis B or active hepatitis C. Hepatitis B carriers, patients with hepatitis B stabilized by antiviral therapy (HBV DNA ≤ 200 IU/mL or copy number \< 1000 copies/mL), and patients with cured hepatitis C (negative HCV RNA) may be enrolled.
• Known active tuberculosis.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Wenhua Li

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Wenhua Li

CONTACT

+86-021-64175590; whliiris@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 22, 2026
• Study Start: November 4, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)