FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02) (TORCH-PM02)
8. září 2026 aktualizováno: 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
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
198
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Zhen Zhang, MD, PhD
- Telefonní číslo: 18801735029
- E-mail: zhen_zhang@fudan.edu.cn
Studijní místa
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Čína, 200032
- Fudan University Shanghai Cancer Center
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Kontakt:
- Zhen Zhang, Prof.
- Telefonní číslo: +8618017312301
- E-mail: zhenzhang_@fudan.edu.cn
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Kontakt:
- Zhiyuan Zhang, M.D.
- Telefonní číslo: +86 18916733704
- E-mail: zhangzhiyuan.1994@163.com
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Vrchní vyšetřovatel:
- Zhen Zhang, Ph.D, M.D.
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Vrchní vyšetřovatel:
- Guoxiang Cai, Ph.D, M.D.
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Progression-Free Survival (PFS)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Overall Survival (OS)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Peritoneal Cancer Index (PCI)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. září 2026
Primární dokončení (Odhadovaný)
1. srpna 2030
Dokončení studie (Odhadovaný)
1. března 2031
Termíny zápisu do studia
První předloženo
1. září 2026
První předloženo, které splnilo kritéria kontroly kvality
8. září 2026
První zveřejněno (Aktuální)
11. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
11. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. září 2026
Naposledy ověřeno
1. září 2026
Více informací
Termíny související s touto studií
Klíčová slova
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