Colon Rectal Cancer AdenocarcinomaPhase 3TORCH-PM02NCT07815834
FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02)
A Phase 3 study testing Second-Line Chemotherapy, Radiation Therapy and Cadonilimab (AK104) in people with Colon Rectal Cancer Adenocarcinoma and Peritoneal (Metastatic) Cancer, run by Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Rectal Cancer Adenocarcinoma, Peritoneal (Metastatic) Cancer, Second-line Treatment
- What is being tested?
- Second-Line Chemotherapy, Radiation Therapy and Cadonilimab (AK104)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 1 Mar 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhen Zhang, Prof., +8618017312301, zhenzhang_@fudan.edu.cn
Zhiyuan Zhang, M.D., +86 18916733704, zhangzhiyuan.1994@163.com
About this study
Official title: 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.
Read more
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
- Conditions
- Colon Rectal Cancer Adenocarcinoma, Peritoneal (Metastatic) Cancer, Second-line Treatment, Radiation Therapy, Immunotherapy
- Being tested
- Second-Line Chemotherapy, Radiation Therapy, Cadonilimab (AK104)
- Keywords
- Colorectal Peritoneal Metastasis, Radiation Therapy, Fapi, TORCH-PM02
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second-Line ChemotherapyDrug
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 TherapyRadiation
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 (AK104)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Chemo-immunotherapy plus FAPI-guided radiotherapy | Experimental | 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. Receives: Drug: Second-Line Chemotherapy; Radiation: Radiation Therapy; Drug: Cadonilimab (AK104) |
| Standard second-line chemotherapy only | Active comparator | 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. Receives: Drug: Second-Line Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
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.
Measured: Up to 36 months after randomization
Secondary outcomes (5)
Overall Survival (OS)
Survival duration from randomization until death from any cause.
Measured: OS is defined from randomization until death from any cause up to 36 months.
Objective Response Rate (ORR)
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.
Measured: 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)
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.
Measured: 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
Incidence and severity of treatment side effects graded by NCI CTCAE v6.0.
Measured: 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)
Patient self-assessment via EORTC QLQ-C30 questionnaire to monitor changes in quality of life throughout treatment.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Rectal Cancer AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815834
- Sponsor's protocol ID
- FDRT-2026-426-5278
- Acronym
- TORCH-PM02
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No