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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 septembre 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

198

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200032
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Contact:
        • Chercheur principal:
          • Zhen Zhang, Ph.D, M.D.
        • Chercheur principal:
          • Guoxiang Cai, Ph.D, M.D.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: 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.
Radiation: 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.
Médicament: 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.
Comparateur actif: 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.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression-Free Survival (PFS)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall Survival (OS)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Change in Peritoneal Cancer Index (PCI)
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Fudan University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 août 2030

Achèvement de l'étude (Estimé)

1 mars 2031

Dates d'inscription aux études

Première soumission

1 septembre 2026

Première soumission répondant aux critères de contrôle qualité

8 septembre 2026

Première publication (Réel)

11 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • FDRT-2026-426-5278

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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