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FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02) (TORCH-PM02)

8. september 2026 oppdatert av: Zhen Zhang, Fudan University

FAPI-Guided Hypofractionated Radiotherapy Combined With Cadonilimab and Standard Second-Line Chemotherapy Versus Standard Second-Line Chemotherapy for Peritoneal Metastasis From Colorectal Cancer: A Multicenter, Randomized, Open-Label, Phase III Trial (TORHC-PM02)

The goal of this clinical trial is to test whether adding targeted radiation plus cadonilimab immunotherapy to standard second-line chemo works better for adults with colorectal cancer only spread to the peritoneum, and check how safe this combined treatment is. Its main research questions are:

Does the combined treatment slow cancer growth for a longer time than standard chemo alone? What side effects will participants get from the new combination therapy? Researchers will compare the chemo-radiation-immunotherapy combination against standard chemo alone to see if the new plan shrinks tumors and improves outcomes.

Participants will:

Receive either the new combined treatment or standard chemo chosen randomly by chance Visit the hospital regularly for drug infusions, scans and physical exams Complete questionnaires about daily quality of life and report any discomfort

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

198

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200032
        • Fudan University Shanghai Cancer Center
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Zhen Zhang, Ph.D, M.D.
        • Hovedetterforsker:
          • Guoxiang Cai, Ph.D, M.D.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Histopathologically confirmed colorectal adenocarcinoma.
  2. Tumors confirmed pMMR by immunohistochemistry or MSI-L/MSS via gene sequencing.
  3. Metastases limited to peritoneum only, no metastases in other organs.
  4. No moderate or massive ascites; only trivial physiological effusion without drainage requirement.
  5. No symptomatic intestinal obstruction and no obstructive signs on imaging; patients can take food normally.
  6. Baseline CT/MRI confirms peritoneal metastases.
  7. Positive baseline FAPI PET/CT: at least one peritoneal mass lesion with long diameter ≥1 cm and markedly elevated SUVmax suitable for radiotherapy contouring.
  8. At least one measurable lesion per RECIST v1.1 criteria.
  9. Progression after first-line standard systemic therapy (FOLFOX/XELOX ± targeted agents); no prior second-line treatment received.
  10. Peritoneal recurrence within 1 year after adjuvant fluoropyrimidine-based chemotherapy.
  11. No moderate or massive ascites; only trivial physiological effusion without drainage requirement.
  12. Voluntarily sign written informed consent and comply with scheduled study visits and treatment procedures.

Exclusion Criteria:

  1. Prior exposure to any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or other agents targeting T-cell co-stimulatory/checkpoint pathways.
  2. Moderate or massive ascites requiring clinical intervention.
  3. Partial or complete symptomatic intestinal obstruction.
  4. Pregnant or breastfeeding women.
  5. History of high-dose abdominal radiotherapy that prevents re-irradiation.
  6. Diffuse miliary peritoneal metastases on FAPI PET/CT without definable target volume for radiotherapy.
  7. Active autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc.); systemic corticosteroids or other immunosuppressants required within 14 days before enrollment; severe underlying vital organ disease judged unsuitable for immunotherapy by investigators.
  8. Poor compliance or other conditions judged inappropriate for study participation by investigators.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Chemo-immunotherapy plus FAPI-guided radiotherapy
Participants receive standard second-line chemotherapy combined with cadonilimab immunotherapy given every two weeks. They also receive hypofractionated radiotherapy guided by FAPI PET/CT to treat peritoneal tumor masses. Radiation doses are adjusted to protect the small intestine. After every eight weeks of treatment, a multidisciplinary team assesses whether surgery is possible. Treatment continues until cancer worsens or side effects become too severe to tolerate.
Legemiddel: Second-Line Chemotherapy
All chemotherapy agents are given by intravenous infusion every 2 weeks with oxaliplatin, leucovorin and continuous infusion fluorouracil, or irinotecan, leucovorin and continuous infusion fluorouracil. Targeted agents bevacizumab or cetuximab can be added per investigator's clinical judgment. Dose adjustments are allowed for myelosuppression, gastrointestinal or other toxicities.
Stråling: Radiation Therapy
Radiation target volumes are contoured on fused FAPI PET/CT images for peritoneal masses ≥1 cm. Fraction doses range from 5 Gy to 25 Gy over 5 fractions, modified to meet small intestine organ-at-risk constraints. Radiation is delivered within the first 8 weeks of combined chemoimmunotherapy treatment.
Legemiddel: Cadonilimab (AK104)
Cadonilimab is a PD-1/CTLA-4 dual-target biologic agent. The fixed dose of 6 mg/kg is infused intravenously once every 2 weeks alongside chemotherapy. Dose delay or permanent discontinuation will be applied for grade 3-4 immune-related adverse events that do not improve with immunosuppressive treatment.
Aktiv komparator: Standard second-line chemotherapy only
Participants receive standard second-line chemotherapy every two weeks. No immunotherapy or radiation treatment is provided in this group. Treatment continues until cancer worsens or side effects become too severe to tolerate. Tumor assessment will be performed after 8 weeks of therapy, a multidisciplinary team assesses whether surgery is possible. Treatment continues until cancer worsens or side effects become too severe to tolerate.
Legemiddel: Second-Line Chemotherapy
All chemotherapy agents are given by intravenous infusion every 2 weeks with oxaliplatin, leucovorin and continuous infusion fluorouracil, or irinotecan, leucovorin and continuous infusion fluorouracil. Targeted agents bevacizumab or cetuximab can be added per investigator's clinical judgment. Dose adjustments are allowed for myelosuppression, gastrointestinal or other toxicities.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: Up to 36 months after randomization
Time from randomization to first documentation of tumor progression (including enlargement of target lesions, new distant metastases, or new onset of ascites) or death from any cause, whichever occurs first, assessed per RECIST v1.1.
Up to 36 months after randomization

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: OS is defined from randomization until death from any cause up to 36 months.
Survival duration from randomization until death from any cause.
OS is defined from randomization until death from any cause up to 36 months.
Objective Response Rate (ORR)
Tidsramme: The best overall tumor response will be assessed every 8 weeks after the participant begins study treatment by scheduled MDT assessment through study completion, up to 36 months.
The best overall tumor response rate, defined as the proportion of participants achieving confirmed complete response or partial response assessed via imaging based on RECIST 1.1 criteria and verified by multidisciplinary team review.
The best overall tumor response will be assessed every 8 weeks after the participant begins study treatment by scheduled MDT assessment through study completion, up to 36 months.
Disease Control Rate (DCR)
Tidsramme: The best overall disease control rate will be assessed every 8 weeks after the participant begins study treatment by scheduled MDT assessment through study completion, up to 36 months.
The best overall disease control rate, defined as the proportion of participants with confirmed complete response, partial response or stable disease assessed via imaging based on RECIST 1.1 criteria and verified by multidisciplinary team review.
The best overall disease control rate will be assessed every 8 weeks after the participant begins study treatment by scheduled MDT assessment through study completion, up to 36 months.
Treatment-related adverse events
Tidsramme: Side effects will be recorded from the participant's first study treatment dose with radiotherapy and system treatment every cycle to 30 days after their final study treatment dose through study completion, up to 36 months.
Incidence and severity of treatment side effects graded by NCI CTCAE v6.0.
Side effects will be recorded from the participant's first study treatment dose with radiotherapy and system treatment every cycle to 30 days after their final study treatment dose through study completion, up to 36 months.
Quality of life( QoL)
Tidsramme: At baseline and radiotherapy period will be reorded once, at system treatments QoL will be reported and recorded every 8 weeks regularly during the treatment through study completion, up to 36 months.
Patient self-assessment via EORTC QLQ-C30 questionnaire to monitor changes in quality of life throughout treatment.
At baseline and radiotherapy period will be reorded once, at system treatments QoL will be reported and recorded every 8 weeks regularly during the treatment through study completion, up to 36 months.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Peritoneal Cancer Index (PCI)
Tidsramme: At baseline and every 8 weeks fixed assessment time points during treatment by scheduled MDT assessment through study completion, up to 36 months.
PCI score reflecting peritoneal tumor burden is measured on FAPI PET/CT images to observe tumor load variations.
At baseline and every 8 weeks fixed assessment time points during treatment by scheduled MDT assessment through study completion, up to 36 months.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fudan University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. august 2030

Studiet fullført (Antatt)

1. mars 2031

Datoer for studieregistrering

Først innsendt

1. september 2026

Først innsendt som oppfylte QC-kriteriene

8. september 2026

Først lagt ut (Faktiske)

11. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FDRT-2026-426-5278

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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