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 uppdaterad 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
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
198
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Zhen Zhang, MD, PhD
- Telefonnummer: 18801735029
- E-post: zhen_zhang@fudan.edu.cn
Studieorter
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200032
- Fudan University Shanghai Cancer Center
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Kontakt:
- Zhen Zhang, Prof.
- Telefonnummer: +8618017312301
- E-post: zhenzhang_@fudan.edu.cn
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Kontakt:
- Zhiyuan Zhang, M.D.
- Telefonnummer: +86 18916733704
- E-post: zhangzhiyuan.1994@163.com
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Huvudutredare:
- Zhen Zhang, Ph.D, M.D.
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Huvudutredare:
- Guoxiang Cai, Ph.D, M.D.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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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.
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Progression-Free Survival (PFS)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Overall Survival (OS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change in Peritoneal Cancer Index (PCI)
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 augusti 2030
Avslutad studie (Beräknad)
1 mars 2031
Studieregistreringsdatum
Först inskickad
1 september 2026
Först inskickad som uppfyllde QC-kriterierna
8 september 2026
Första postat (Faktisk)
11 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FDRT-2026-426-5278
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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Nej
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