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Colorectal CancerPhase 2NCT07079462

Comparing 18F-FAPI PET-Guided Abdominal Radiotherapy Combined With Second-Line Standard Therapy and Cadonilimab Versus Second-Line Standard Therapy in Colorectal Cancer With Peritoneal Metastasis

A Phase 2 study testing Radiotherapy followed by immunotherapy and chemotherapy in people with Colorectal Cancer and Peritoneal (Metastatic) Cancer, run by Fudan University at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Main objective: 1. To compare the objective response rate (ORR) of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cadonilimab and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer. Secondary objectives: 1. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Radiotherapy followed by immunotherapy and chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesChina
Study dates
7 Aug 2024to 31 Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age of 18 years or older. 2. Peritoneal metastasis of colorectal cancer confirmed by histological or cytological examination (International Union Against Cancer 8th edition of colorectal cancer staging).
  • 3. Progression after receiving standard first-line treatment before enrollment; but excluding any type of immunotherapy.
  • 4. Eastern Cooperative Oncology Group (ECOG) score of 0-1, with an expected survival time of more than 6 months.
  • 5. ECOG score of 0-1. 6. Expected survival time of ≥ 24 weeks. 7. Laboratory tests for bone marrow, liver and kidney organ functions and coagulation function within 7 days before the first administration were in compliance with the study requirements (no blood transfusion, blood products, use of granulocyte colony-stimulating factor or other hematopoietic stimulating factors for correction within 7 days before the laboratory tests).
  • 8. Women with reproductive capacity must have a negative blood pregnancy test result within 7 days before the first administration. Male or female patients with reproductive capacity voluntarily use effective contraceptive methods during the study period and within 6 months after the last study medication, such as double barrier contraceptive methods, condoms, oral or injectable contraceptive drugs, intrauterine devices, abstinence, etc. All female patients will be considered to have reproductive capacity, unless the female patient has naturally menopause, artificial menopause or sterilization (uterus removal, bilateral ovary removal).
  • 9. Voluntary enrollment and signing of informed consent form, following the trial treatment plan and visit schedule.

Who cannot join

  • 1. Absolute neutrophil count (ANC) < 1.5 × 109/L, or platelet count < 100 × 109/L (for patients with liver metastasis, platelet count < 80 × 109/L), or hemoglobin < 9 g/dL; blood transfusion within 2 weeks prior to enrollment is not allowed to meet the inclusion criteria.
  • 2. Serum total bilirubin > 1.5 times the upper limit of normal (ULN); for patients with liver metastasis, > 2.5 times ULN.
  • 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 times ULN, or for patients with liver metastasis, ALT and/or AST > 5 times ULN.
  • 4. Serum creatinine > 1.5 times ULN, or creatinine clearance rate < 50 ml/min (calculated according to the Cockcroft-Gault formula).
  • 5. Partial thromboplastin time (APTT) or prothrombin time (PT) > 1.5 times ULN (based on the normal values of the clinical trial center).
  • 6. The researcher determines clinically significant severe electrolyte abnormalities.
Show all 18Show fewer
  • 7. Urine protein test of 2+ or above, or 24-hour urine protein quantification ≥ 1.0 g/24h.
  • 8. Hypertension that is not well controlled by medication, defined as: systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg.
  • 9. The patient currently has active peptic ulcer, ulcerative colitis, or other digestive tract diseases or active bleeding from an unresected tumor, or the researcher determines that it may cause gastrointestinal bleeding or perforation; or if there was a previous gastrointestinal perforation or gastrointestinal fistula, and the patient has not recovered after surgical treatment.
  • 10. Within 6 months before enrollment, there is a history of arterial thrombosis or deep vein thrombosis, or within 2 months before enrollment, there is evidence or history of bleeding tendency or history of bleeding, regardless of severity.
  • 11. Within 12 months before enrollment, a stroke event or transient ischemic attack occurred.
  • 12. Within 6 months before enrollment, heart disease including congestive heart failure, acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass surgery; or NYHA class 2 or above heart dysfunction patients; left ventricular ejection fraction (LVEF) < 50%.
  • 13. Uncontrolled malignant pleural effusion, ascites or pericardial effusion (defined as not being effectively controlled by diuretics or puncture as determined by the researcher).
  • 14. Any patient who has received any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody (or any other antibody acting on the T cell co-stimulation or checkpoint pathways) before enrollment.
  • 15. Within 4 weeks before enrollment, received any form of radiotherapy. 16. At the screening stage, there is a clinically detectable second primary malignant tumor, or other malignant tumors occurred in the past 5 years, excluding fully treated non-melanoma skin cancer, cervical carcinoma in situ and superficial bladder tumor [non-invasive tumors, carcinoma in situ and T1 (tumor invasion of the lamina propria)], if present.
  • 17. Known clinical significance of liver disease history, including but not limited to known hepatitis B virus (HBV) infection and positive HBV DNA (≥ 1 × 104/ml); known hepatitis C virus (HCV) infection and positive HCV RNA (≥ 1 × 103/ml), or liver cirrhosis, etc.
  • 18. Pregnant or lactating women or women with a possibility of pregnancy who have a positive pregnancy test before the first medication; or female participants who are unwilling to implement strict contraception during the study.
  • The researcher considers that the subject has any clinical or laboratory abnormalities or non-compliance issues that make them unsuitable to participate in this clinical study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Fudan University Shanghai Cancer Center

    Shanghai

Other trials in China

About this study

Official title: A Prospective Randomized Controlled Study Comparing 18F-FAPI PET-Guided Abdominal Radiotherapy Combined With Second-Line Standard Therapy and Cadonilimab Versus Second-Line Standard Therapy in Colorectal Cancer With Peritoneal Metastasis

Main objective:

  1. To compare the objective response rate (ORR) of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cadonilimab and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer.
Read more

Secondary objectives:

  1. To compare the disease control rate (DCR), duration of continuous remission (DoR), progression-free survival (PFS) and overall survival (OS) of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cadonilimab and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer.
  2. To evaluate the safety and tolerability of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cadonilimab.
Being tested
Radiotherapy followed by immunotherapy and chemotherapy, Chemotherapy (control)
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiotherapy followed by immunotherapy and chemotherapyCombination product

    Radiotherapy: The prescribed dose is 20-25Gy in 5 daily fractions to all or part of the target lesions.

    Immunotherapy: One week after the completion of radiotherapy, standard chemotherapy with cadonilimab, 6 mg/kg, is administered every two weeks.

    Standard second-line systemic therapy: Standard second-line systemic therapy: (XELOX/FOLFOX or XELIRI/FOLFIRI ± bevacizumab/cetuximab)

  • Chemotherapy (control)Drug

    Standard second-line treatment regimen: (XELOX/FOLFOX or XELIRI/FOLFIRI ± bevacizumab/ cetuximab)

Study groups in NCT07079462
Study groupRoleWhat they receive
Radiotherapy+Immunotherapy+Standard second-line systemic therapyExperimentalRadiotherapy: The prescribed dose is 20-25Gy in 5 daily fractions to all or part of the target lesions. Immunotherapy: One week after the completion of radiotherapy, standard chemotherapy with cadonilimab, 6 mg/kg, is administered every two weeks. Standard second-line systemic therapy: Standard second-line systemic therapy: (XELOX/FOLFOX or XELIRI/FOLFIRI ± bevacizumab/cetuximab)
Receives: Combination Product: Radiotherapy followed by immunotherapy and chemotherapy
Standard second-line systemic therapyActive comparatorStandard second-line systemic therapy: (XELOX/FOLFOX or XELIRI/FOLFIRI ± bevacizumab/cetuximab)
Receives: Drug: Chemotherapy (control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    ORR is defined as the proportion of randomized participants with a best overall response of CR or PR according to RECIST Version 1.1. Tumor assessments are performed every 8 weeks.

    Measured: Every 8 weeks from randomization until disease progression or CRS, up to study completion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start7 Aug 2024
  3. Primary completion31 Jan 2026
  4. Study completion31 Jan 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07079462
Sponsor's protocol ID
TORCH-PM01
Status last verified
Jun 2026
First submitted
12 Jul 2025
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy followed by immunotherapy and chemotherapy in people with Colorectal Cancer and Peritoneal (Metastatic) Cancer, run by Fudan University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: Every 8 weeks from randomization until disease progression or CRS, up to study completion.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07079462.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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