FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02) (TORCH-PM02)
8 settembre 2026 aggiornato da: 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
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
198
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Zhen Zhang, MD, PhD
- Numero di telefono: 18801735029
- Email: zhen_zhang@fudan.edu.cn
Luoghi di studio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200032
- Fudan University Shanghai Cancer Center
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Contatto:
- Zhen Zhang, Prof.
- Numero di telefono: +8618017312301
- Email: zhenzhang_@fudan.edu.cn
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Contatto:
- Zhiyuan Zhang, M.D.
- Numero di telefono: +86 18916733704
- Email: zhangzhiyuan.1994@163.com
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Investigatore principale:
- Zhen Zhang, Ph.D, M.D.
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Investigatore principale:
- Guoxiang Cai, Ph.D, M.D.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Histopathologically confirmed colorectal adenocarcinoma.
- Tumors confirmed pMMR by immunohistochemistry or MSI-L/MSS via gene sequencing.
- Metastases limited to peritoneum only, no metastases in other organs.
- No moderate or massive ascites; only trivial physiological effusion without drainage requirement.
- No symptomatic intestinal obstruction and no obstructive signs on imaging; patients can take food normally.
- Baseline CT/MRI confirms peritoneal metastases.
- Positive baseline FAPI PET/CT: at least one peritoneal mass lesion with long diameter ≥1 cm and markedly elevated SUVmax suitable for radiotherapy contouring.
- At least one measurable lesion per RECIST v1.1 criteria.
- Progression after first-line standard systemic therapy (FOLFOX/XELOX ± targeted agents); no prior second-line treatment received.
- Peritoneal recurrence within 1 year after adjuvant fluoropyrimidine-based chemotherapy.
- No moderate or massive ascites; only trivial physiological effusion without drainage requirement.
- Voluntarily sign written informed consent and comply with scheduled study visits and treatment procedures.
Exclusion Criteria:
- 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.
- Moderate or massive ascites requiring clinical intervention.
- Partial or complete symptomatic intestinal obstruction.
- Pregnant or breastfeeding women.
- History of high-dose abdominal radiotherapy that prevents re-irradiation.
- Diffuse miliary peritoneal metastases on FAPI PET/CT without definable target volume for radiotherapy.
- 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.
- Poor compliance or other conditions judged inappropriate for study participation by investigators.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
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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 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.
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.
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Comparatore attivo: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Progression-Free Survival (PFS)
Lasso di tempo: Up to 36 months after randomization
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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.
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Up to 36 months after randomization
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Overall Survival (OS)
Lasso di tempo: OS is defined from randomization until death from any cause up to 36 months.
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Survival duration from randomization until death from any cause.
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OS is defined from randomization until death from any cause up to 36 months.
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Objective Response Rate (ORR)
Lasso di tempo: 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.
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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.
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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.
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Disease Control Rate (DCR)
Lasso di tempo: 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.
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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.
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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.
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Treatment-related adverse events
Lasso di tempo: 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.
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Incidence and severity of treatment side effects graded by NCI CTCAE v6.0.
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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.
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Quality of life( QoL)
Lasso di tempo: 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.
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Patient self-assessment via EORTC QLQ-C30 questionnaire to monitor changes in quality of life throughout treatment.
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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.
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in Peritoneal Cancer Index (PCI)
Lasso di tempo: At baseline and every 8 weeks fixed assessment time points during treatment by scheduled MDT assessment through study completion, up to 36 months.
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PCI score reflecting peritoneal tumor burden is measured on FAPI PET/CT images to observe tumor load variations.
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At baseline and every 8 weeks fixed assessment time points during treatment by scheduled MDT assessment through study completion, up to 36 months.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
1 agosto 2030
Completamento dello studio (Stimato)
1 marzo 2031
Date di iscrizione allo studio
Primo inviato
1 settembre 2026
Primo inviato che soddisfa i criteri di controllo qualità
8 settembre 2026
Primo Inserito (Effettivo)
11 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- FDRT-2026-426-5278
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .