Rectal CancerPhase 1ACO/ARO/AIO-21NCT04942626
Capecitabine-based Chemoradiotherapy in Combination With the IL-1 Receptor Antagonist Anakinra for Rectal Cancer Patients
A Phase 1 study testing Kineret 100 MG in 0.67 ML Prefilled Syringe, Capecitabine and Radiotherapy in people with Rectal Cancer, run by Goethe University at 1 site in Germany.
Trial summary
The ACO/ARO/AIO-21 investigator-driven, open-labeled, phase I drug re-purposing trial will assess whether the IL-1 receptor antagonist Anakinra can be safely combined with fluoropyrimidine-based chemoradiotherapy (CRT) in patients with rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Kineret 100 MG in 0.67 ML Prefilled Syringe, Capecitabine and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 20 Aug 2021to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localized 0 - 12 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower and middle third of the rectum)
- Staging requirements: High-resolution, thin-sliced (i.e. 3 mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
- Patients with MRI-defined low risk rectal cancer with the presence of at least one of the following conditions:
- cT2N0 or cT3a/bN0 tumors ≤6 cm from the anocutaneous line that would require abdominoperineal resection or permanent colostomy
- Any rectal cancer of the upper third (12-16 cm) requiring FU-CRT according to German S3 guideline recommendations (i.e. cT4, mrCRM+, extensive N+)
- Patients with MRI-defined intermediate/high risk rectal cancer, but not eligible for TNT (oxaliplatin-containing) protocols:
Show all 22Show fewer
- any cT3 if the distal extent of the tumor is < 6 cm from the anocutaneous line, or
- cT3c/d in the middle third of the rectum (≥ 6-12 cm) with MRI evidence of extramural tumor spread into the mesorectal fat of more than 5 mm (>cT3b), or
- cT3 with clear cN1 based on strict MRI-criteria (see appendix)
- cT4 tumors, or
- Tany middle/low third of rectum with clear MRI criteria for N2
- mrCRM+ (≤ 1mm), or
- Extramural venous invasion (EMVI+)
- Trans-rectal endoscopic ultrasound (EUS) is additionally used when MRI is not definitive to exclude early cT1 disease in the lower third or middle third of the rectum.
- Spiral-CT of the abdomen and chest to exclude distant metastases.
- Aged at least 18 years. No upper age limit
- WHO/ECOG Performance Status ≤1
- Adequate hematological, hepatic, renal and metabolic function parameters:
- Leukocytes ≥ 3.000/mm^3, ANC ≥ 1.500/mm^3, platelets ≥ 100.000/mm^3, Hb > 9 g/dl
- Serum creatinine ≤ 1.5 x upper limit of normal
- Bilirubin ≤ 2.0 mg/dl, SGOT-SGPT, and AP ≤ 3 x upper limit of normal
- Informed consent of the patient
Who cannot join
- Distant metastases (to be excluded by CT scan of the thorax and abdomen)
- Prior antineoplastic therapy for rectal cancer
- Prior radiotherapy of the pelvic region
- Major surgery within the last 4 weeks prior to inclusion
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- Subject (male or female) is not willing to use highly effective methods of contraception during treatment and for 6 months after the end of treatment.
Show all 35Show fewer
- On-treatment participation in a clinical study in the period 30 days prior to inclusion
- Previous or current drug abuse
- Other concomitant antineoplastic therapy
- Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder
- Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrolment
- Prior or concurrent malignancy ≤ 3 years prior to enrolment in study (Exception: non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1), if the patient is continuously disease-free
- Known allergic reactions on study medication
- Known dihydropyrimidine dehydrogenase deficiency
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial).
- History of severe hepatic impairment (e.g. Child-Pugh = Grade C)
- Moderate (Creatinine Clearance 30 to 49 mL/minute), severe (Creatinine Clearance <30 mL/minute) renal impairment
- Neutropenia (neutrophil count <1.5x109/l)
- Known hypersensitivity to Anakinra or E. coli derived proteins, Anakinra or any of the components of the product
- Asthma
- Patients with clinically significant bacterial, fungal, parasitic or viral infection, which require acute therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed
- Patients with known active hepatitis B, C or who are HIV-positive or who are at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Prior test results obtained as part of standard of care that confirm a subject is immune and not at risk for reactivation (ie, hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility and tests do not need to be repeated. Subjects with prior positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.
- Subjects who are already using the following medications will not be allowed:
- Tumor necrosis alpha inhibitors: Use on any of these biologics within 8 weeks of screening or baseline visit.
- IL-6 inhibitors: Use of any IL-6 inhibitors within 8 weeks of screening or baseline visit
- Janus Kinase inhibitors: Use of baricitinib, tofacinitib, upadacitinib, and ruxolitinib, oclacitinib, fedratinib, within 2 weeks from screening or baseline visit.
- Bruton's tyrosine kinase inhibitors: Ibrutinib, acalabrutinib, zanubrutinib
- CCR5 antagonist (CCR5 = C-C Chemokine Receptor Type 5; DMARD = Disease Modifying Anti-Rheumatic Drug): Leronlimab is also an immunomodulator.
- DMARDs: cyclosporine, cyclophosphamide, mycophenolic acid, chlorambucil, penicillamine, azathioprine: Use within 6 months prior to screening or baseline visit.
- Rituximab: Use of rituximab within 1 year of screening or baseline visit.
- Abatacept: Use of abatacept within 8 weeks of screening or baseline visit.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
- Patients under ongoing treatment with another investigational medication or having been treated with an investigational medication within 30 days (incl. live attenuated vaccine) of screening or 5 half-lives (whichever is longer) prior to the first dose of investigational product
- Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed
- History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the subject at high risk for treatment complications.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Goethe University Frankfurt
Frankfurt, 60590
About this study
Official title: Capecitabine-based Chemoradiotherapy in Combination With the IL-1 Receptor Antagonist Anakinra for Rectal Cancer Patients. A Phase I Trial of the German Rectal Cancer Study Group
The ACO/ARO/AIO-21 investigator-driven, open-labeled, phase I drug re-purposing trial will assess whether the IL-1 receptor antagonist Anakinra can be safely combined with fluoropyrimidine-based chemoradiotherapy (CRT) in patients with rectal cancer.
Read the detailed description
Preoperative fluoropyrimidine-based chemoradiotherapy (CRT) and total mesorectal excision (TME) surgery 6-10 weeks thereafter, followed by optional adjuvant chemotherapy, has been the standard multimodal treatment for patients with UICC stage II and III rectal cancer during the last two decades. With this, pathological complete response rates (pCR) are in the range of 10%, 3 year-local failure rates in the range of 5%, distant recurrences occur in 25-30% of patients, and 3 years disease-free survival (DFS) amounts to 70%. More recently, total neoadjuvant treatment (TNT) with either 5x5 Gy or fluoropyrimidine-CRT, followed by consolidation chemotherapy with fluorouracil (or capecitabine) and oxaliplatin (FOLFOX/CAPOX), and TME, has significantly improved pCR and DFS compared to standard preoperative FU-CRT (+/- adjuvant chemotherapy) in recent phase 3 trials for patients with high-risk rectal cancer and has recently been accepted as standard treatment for this patient subgroup. In contrast, it remains unclear whether patients with intermediate risk rectal cancer benefit from TNT (currently under investigation in trials), whereas elderly and frail patients are not eligible for TNT and are rather be treated with 5x5 Gy or capecitabine-CRT alone. IL-1 is an inflammatory cytokine that plays a key role in tumor formation, progression and therapy resistance. Extensive studies of our group have showed that IL-1 mediates CRT resistance and disease progression in rectal cancer. Thus, blockade of IL-1 signaling using Anakinra constitutes an attractive option to significantly improve prognosis. The ACO/ARO/AIO-21 phase I drug re-purposing trial will assess whether the IL-1RA Anakinra can be safely combined with CRT in patients with rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Kineret 100 MG in 0.67 ML Prefilled Syringe, Capecitabine, Radiotherapy, Watch and Wait (cCR) or TME surgery (non-cCR)
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kineret 100 MG in 0.67 ML Prefilled SyringeDrug
Anakinra 100 mg s.c. (Kineret) will be administered from day -10 (i.e. 10 days before initiation of RT) to the last day of RT.
CapecitabineDrug
Capecitabine will be administered using a 3+3 dose escalation design (500 mg/m2 bid, 650 mg/m2 bid and 825 mg/m2 bid po, respectively) from day 1 to day 40 of RT including weekends.
RadiotherapyRadiation
PTV: 1.8 Gy to 45 Gy (#28 fractions) to the primary tumor and pelvic lymph nodes; followed by a sequential boost of 1.8 Gy to 9 Gy (#5 fractions) to the gross tumor volume
Watch and Wait (cCR) or TME surgery (non-cCR)Procedure or surgery
Also called W&W or TME
Restaging to evaluate tumor response will be conducted 10 weeks after completion of CRT. For patients achieving a clinical complete response (cCR), a Watch and Wait (W\&W) option with close follow-up is scheduled. In case of non-cCR, immediate total mesorectal excision (TME) surgery is recommended. According to the current German S3-guidelines, adjuvant chemotherapy is optional.
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiotherapy with Anakinra followed by either TME surgery or Watch and Wait | Other | Capecitabine 500 mg/m2 bid or Capecitabine 650 mg/m2 bid or Capecitabine 825 mg/m2 bid combined with Radiotherapy and Kineret Receives: Drug: Kineret 100 MG in 0.67 ML Prefilled Syringe; Drug: Capecitabine; Radiation: Radiotherapy; Procedure: Watch and Wait (cCR) or TME surgery (non-cCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of safety for capecitabine administered concomitantly with standard radiotherapy in combination with Anakinra at a fixed dose of 100 mg s.c.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 16 weeks
Identification of the maximum tolerated dose for capecitabine administered concomitantly with standard radiotherapy in combination with Anakinra at a fixed dose of 100 mg s.c
Identification of the maximum tolerated dose for capecitabine in combination with radiotherapy and Anakinra based on 3+3 design
Measured: 16 weeks
Secondary outcomes (18)
Postoperative complications of (salvage) surgery
Postoperative complications of (salvage) surgery
Measured: 1 year
Late toxicity assessment according to NCI CTCAE V.5.0
Late toxicity assessment according to NCI CTCAE V.5.0
Measured: 3 years
Rate of W&W with or without local regrowth
Rate of W\&W with or without local regrowth
Measured: 3 years
Cumulative incidence of locoregional regrowth after cCR
cumulative incidence of locoregional regrowth after cCR
Measured: 3 years
Rate of salvage surgery (LE/TME with or without APR/stoma) after locoregional regrowth
Rate of salvage surgery (LE/TME with or without APR/stoma) after locoregional regrowth
Measured: 3 years
Cumulative incidence of local recurrence after (salvage) surgery
Cumulative incidence of local recurrence after (salvage) surgery
Measured: 3 years
Cumulative incidence of distant recurrences
Cumulative incidence of distant recurrences
Measured: 3 years
Disease-free survival
Disease-free survival
Measured: 3 years
Overall survival
Overall survival
Measured: 3 years
Pathological TNM-staging
Pathological TNM-staging based on TNM Classification of Malignant Tumors, 8th edition
Measured: 3 years
R0 resection rate;
Rate of complete resection (R0)
Measured: 3 years
negative circumferential resection rate
negative circumferential resection rate
Measured: 3 years
Tumor regression grading according to Dworak
Tumor regression grading according to Dworak
Measured: 3 years
Quality of TME according to MERCURY
Pathological tumor evaluations according to MERCURY classification
Measured: 3 years
Quality of life based on treatment arm and surgical procedures/organ preservation
Quality of life based on EORTC-QLQs-C30
Measured: 3 years
functional outcome based on treatment arm and surgical procedures/organ preservation
functional outcome based on Wexner score
Measured: 3 years
Quality of life based on treatment arm and surgical procedures/organ preservation
Quality of life based on EORTC-QLQs-CR29
Measured: 3 years
Quality of life based on treatment arm and surgical procedures/organ preservation
Quality of life based on EORTC-QLQs-CPIN20
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start20 Aug 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3+3 design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Claus Rödel, Goethe University
- Investigators
- Claus Roedel, Prof. MD, Study chair, University Hospital Goethe University Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942626
- Sponsor's protocol ID
- ACO/ARO/AIO-21
- Acronym
- ACO/ARO/AIO-21
- Status last verified
- Feb 2025
- First submitted
- 25 May 2021
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capecitabine-based Chemoradiotherapy in Combination With the IL-1 Receptor Antagonist Anakinra for Rectal Cancer Patients. A Phase I Trial of the German Rectal Cancer Study Group
- ClinicalTrials.gov ID
- NCT04942626
- Acronym / sponsor ID
- ACO/ARO/AIO-21 / ACO/ARO/AIO-21
- Conditions
- Rectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ACO/ARO/AIO-21 investigator-driven, open-labeled, phase I drug re-purposing trial will assess whether the IL-1 receptor antagonist Anakinra can be safely combined with fluoropyrimidine-based chemoradiotherapy (CRT) in patients with rectal cancer.
Detailed description
Preoperative fluoropyrimidine-based chemoradiotherapy (CRT) and total mesorectal excision (TME) surgery 6-10 weeks thereafter, followed by optional adjuvant chemotherapy, has been the standard multimodal treatment for patients with UICC stage II and III rectal cancer during the last two decades. With this, pathological complete response rates (pCR) are in the range of 10%, 3 year-local failure rates in the range of 5%, distant recurrences occur in 25-30% of patients, and 3 years disease-free survival (DFS) amounts to 70%. More recently, total neoadjuvant treatment (TNT) with either 5x5 Gy or fluoropyrimidine-CRT, followed by consolidation chemotherapy with fluorouracil (or capecitabine) and oxaliplatin (FOLFOX/CAPOX), and TME, has significantly improved pCR and DFS compared to standard preoperative FU-CRT (+/- adjuvant chemotherapy) in recent phase 3 trials for patients with high-risk rectal cancer and has recently been accepted as standard treatment for this patient subgroup. In contrast, it remains unclear whether patients with intermediate risk rectal cancer benefit from TNT (currently under investigation in trials), whereas elderly and frail patients are not eligible for TNT and are rather be treated with 5x5 Gy or capecitabine-CRT alone. IL-1 is an inflammatory cytokine that plays a key role in tumor formation, progression and therapy resistance. Extensive studies of our group have showed that IL-1 mediates CRT resistance and disease progression in rectal cancer. Thus, blockade of IL-1 signaling using Anakinra constitutes an attractive option to significantly improve prognosis. The ACO/ARO/AIO-21 phase I drug re-purposing trial will assess whether the IL-1RA Anakinra can be safely combined with CRT in patients with rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 design
| Arm | Type | Receives |
|---|---|---|
| Chemoradiotherapy with Anakinra followed by either TME surgery or Watch and Wait | Other | Drug: Kineret 100 MG in 0.67 ML Prefilled Syringe, Drug: Capecitabine, Radiation: Radiotherapy, Procedure: Watch and Wait (cCR) or TME surgery (non-cCR)Capecitabine 500 mg/m2 bid or Capecitabine 650 mg/m2 bid or Capecitabine 825 mg/m2 bid combined with Radiotherapy and Kineret |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localized 0 - 12 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower and middle third of the rectum)
- Staging requirements: High-resolution, thin-sliced (i.e. 3 mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
- Patients with MRI-defined low risk rectal cancer with the presence of at least one of the following conditions:
- Patients with MRI-defined intermediate/high risk rectal cancer, but not eligible for TNT (oxaliplatin-containing) protocols:
- Trans-rectal endoscopic ultrasound (EUS) is additionally used when MRI is not definitive to exclude early cT1 disease in the lower third or middle third of the rectum.
Key exclusion criteria (35 listed)
- Distant metastases (to be excluded by CT scan of the thorax and abdomen)
- Prior antineoplastic therapy for rectal cancer
- Prior radiotherapy of the pelvic region
- Major surgery within the last 4 weeks prior to inclusion
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kineret 100 MG in 0.67 ML Prefilled SyringeAnakinra 100 mg s.c. (Kineret) will be administered from day -10 (i.e. 10 days before initiation of RT) to the last day of RT. | Drug | Chemoradiotherapy with Anakinra followed by either TME surgery or Watch and Wait |
| CapecitabineCapecitabine will be administered using a 3+3 dose escalation design (500 mg/m2 bid, 650 mg/m2 bid and 825 mg/m2 bid po, respectively) from day 1 to day 40 of RT including weekends. | Drug | Chemoradiotherapy with Anakinra followed by either TME surgery or Watch and Wait |
| RadiotherapyPTV: 1.8 Gy to 45 Gy (#28 fractions) to the primary tumor and pelvic lymph nodes; followed by a sequential boost of 1.8 Gy to 9 Gy (#5 fractions) to the gross tumor volume | Radiation | Chemoradiotherapy with Anakinra followed by either TME surgery or Watch and Wait |
| Watch and Wait (cCR) or TME surgery (non-cCR)Also: W&W or TMERestaging to evaluate tumor response will be conducted 10 weeks after completion of CRT. For patients achieving a clinical complete response (cCR), a Watch and Wait (W\&W) option with close follow-up is scheduled. In case of non-cCR, immediate total mesorectal excision (TME) surgery is recommended. According to the current German S3-guidelines, adjuvant chemotherapy is optional. | Procedure or surgery | Chemoradiotherapy with Anakinra followed by either TME surgery or Watch and Wait |
Primary outcome
Analysis of safety for capecitabine administered concomitantly with standard radiotherapy in combination with Anakinra at a fixed dose of 100 mg s.c.
Time frame: 16 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Identification of the maximum tolerated dose for capecitabine administered concomitantly with standard radiotherapy in combination with Anakinra at a fixed dose of 100 mg s.c
Time frame: 16 weeks
Identification of the maximum tolerated dose for capecitabine in combination with radiotherapy and Anakinra based on 3+3 design
18 secondary outcomes
Postoperative complications of (salvage) surgery
Time frame: 1 year
Late toxicity assessment according to NCI CTCAE V.5.0
Time frame: 3 years
Rate of W&W with or without local regrowth
Time frame: 3 years
Cumulative incidence of locoregional regrowth after cCR
Time frame: 3 years
Rate of salvage surgery (LE/TME with or without APR/stoma) after locoregional regrowth
Time frame: 3 years
Cumulative incidence of local recurrence after (salvage) surgery
Time frame: 3 years
Cumulative incidence of distant recurrences
Time frame: 3 years
Disease-free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Pathological TNM-staging
Time frame: 3 years
R0 resection rate;
Time frame: 3 years
negative circumferential resection rate
Time frame: 3 years
Tumor regression grading according to Dworak
Time frame: 3 years
Quality of TME according to MERCURY
Time frame: 3 years
Quality of life based on treatment arm and surgical procedures/organ preservation
Time frame: 3 years
functional outcome based on treatment arm and surgical procedures/organ preservation
Time frame: 3 years
Quality of life based on treatment arm and surgical procedures/organ preservation
Time frame: 3 years
Quality of life based on treatment arm and surgical procedures/organ preservation
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus Roedel, Prof. MD study chair
University Hospital Goethe University Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kineret 100 MG in 0.67 ML Prefilled Syringe, Capecitabine and Radiotherapy in people with Rectal Cancer, run by Goethe University at 1 site in Germany.
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 22 inclusion and 35 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: finished, as of the sponsor's last update on 17 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 1 site in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Analysis of safety for capecitabine administered concomitantly with standard radiotherapy in combination with Anakinra at a fixed dose of 100 mg s.c. (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.