Locally Advanced Rectal CancerPhase 2NCT05980689
Combination of AK104 and Neoadjuvant Chemoradiotherapy in pMMR/MSS Locally Advanced Rectal Cancer
A Phase 2 study testing AK104, Capecitabine and Neoadjuvant Radiotherapy in people with Locally Advanced Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is an open-label, single-arm study to investigate the efficacy and safety of AK104 (an Anti-PD1 and Anti-CTLA4 Bispecific Antibody) and neoadjuvant chemoradiotherapy in patients with pMMR/MSS locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- AK104, Capecitabine and Neoadjuvant Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2023to 31 Jan 2025
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75
- ECOG 0-1
- Rectal adenocarcinoma
- cT3-4aNany or cT1-4aN+
- No distant metastasis
- Location ≤12 cm from the anal verge
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- Positive PD-L1 expression (PD-L1 TPS≥1% or PD-L1 CPS ≥1)
- the MSI status is MSS and pMMR
- Sufficient bone marrow, kidney and liver function
- No previous surgery of the rectum, no previous chemotherapy, no previous pelvic radiation, no previous biotherapy, no immunotherapy
Who cannot join
- bowel obstruction
- Distant metastasis
- Severe arrhythmia, cardiac dysfunction (NYHA grade III or IV )
- Uncontrollable severe hypertesion
- Active severe infection
- Cachexia, organ dysfunction
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- Previous pelvic radiotherapy or chemotherapy
- Multiple primary cancers
- Epileptic seizures
- Malignant history within 5 years, except cervical carcinoma in situ or cutaneous basal cell carcinoma
- Persons deprived of liberty or under guardianship
- Impossibility for compliance to follow-up
- Certain or suspicious allergy to research drug
- Pregnant or breast-feeding woman
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
WeiWei xiao, 8613710390520 ext. 8613710390520, xiaoww@sysucc.org.cn
About this study
Official title: A Phase II Trial of AK104 Combined With Neoadjuvant Chemoradiotherapy in Proficient Mismatch Repair/Microsatellite Stable Locally Advanced Rectal Cancer
This is an open-label, single-arm study to investigate the efficacy and safety of AK104 (an Anti-PD1 and Anti-CTLA4 Bispecific Antibody) and neoadjuvant chemoradiotherapy in patients with pMMR/MSS locally advanced rectal cancer.
Read the detailed description
The study evaluates the addition of AK104(an Anti-PD1 and Anti-CTLA4 Bispecific Antibody) in neoadjuvant chemoradiotherapy in proficient Mismatch Repair (pMMR) /Microsatellite Stable (MSS) locally advanced rectal cancer (LARC). A total of 33 pMMR/MSS LARC patients will receive long-course chemoradiotherapy plus 2 cycles of AK104, followed by another 3 cycles of AK104, finally received clinical routine manage. The tumor response to treatment, adverse effects and long-term prognosis will be analyzed.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- AK104, Capecitabine, Neoadjuvant Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104Drug
Also called Cadonilimab
During neo-CRT: 2 cycles of AK104, 10mg/kg d1 q3w. After neo-CRT: 3 cycles of AK104, 10mg/kg d1 q3w.
CapecitabineDrug
During neo-CRT: 825mg/m2 bid Monday-Friday per week
Neoadjuvant RadiotherapyRadiation
IMRT DT: 50Gy/25Fx
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | A total of 33 pMMR/MSS LARC patients will receive long-course chemoradiotherapy plus 2 cycles of AK104, followed by another 3 cycles of AK104, finally received clinical routine manage. Receives: Drug: AK104; Drug: Capecitabine; Radiation: Neoadjuvant Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR) rate
Rate of complete response (CR), including pathologic complete response (pCR) and clinical complete response (cCR).
Measured: an average of 6 months.
Secondary outcomes (7)
Adverse effects
Adverse effects according to CTCAE 5.0
Measured: From date of randomization until the date of death from any cause, assessed up to 5 years
Rate of Major pathologic response and tumor regression grade distribution
Rate of Major pathologic response and tumor regression grade distribution
Measured: an average of 1 year.
Rate of surgical complications
Rate of surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
Measured: The surgery was scheduled 2-4 weeks after the end of neoadjuvant therapy. And the surgical complications were assessed up to 1 year from the surgery.
Disease free survival
3 year disease free survival rate
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Local recurrence free survival
3 year local recurrence free survival rate
Measured: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.
Overall survival
5 year overall survival rate
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months.
Long-term anal function
Long-term anal function was evaluated using the Wexner Continence Grading Scale ,the score being calculated after the patients' completion of a daily defecatory questionnaire. Range is from 0 (normal continence) to 20 (maximum incontinence with maximum disturbance of lifestyle)
Measured: 1.5 year after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start24 Oct 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Akeso, Haplox Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, WeiWei Xiao, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980689
- Sponsor's protocol ID
- B2022-766-01
- Status last verified
- Feb 2024
- First submitted
- 26 Jul 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of AK104 Combined With Neoadjuvant Chemoradiotherapy in Proficient Mismatch Repair/Microsatellite Stable Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT05980689
- Acronym / sponsor ID
- B2022-766-01
- Conditions
- Locally Advanced Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Akeso, Haplox Biotechnology Co., Ltd.
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 8 Aug 2023 (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.
This is an open-label, single-arm study to investigate the efficacy and safety of AK104 (an Anti-PD1 and Anti-CTLA4 Bispecific Antibody) and neoadjuvant chemoradiotherapy in patients with pMMR/MSS locally advanced rectal cancer.
Detailed description
The study evaluates the addition of AK104(an Anti-PD1 and Anti-CTLA4 Bispecific Antibody) in neoadjuvant chemoradiotherapy in proficient Mismatch Repair (pMMR) /Microsatellite Stable (MSS) locally advanced rectal cancer (LARC). A total of 33 pMMR/MSS LARC patients will receive long-course chemoradiotherapy plus 2 cycles of AK104, followed by another 3 cycles of AK104, finally received clinical routine manage. The tumor response to treatment, adverse effects and long-term prognosis will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: AK104, Drug: Capecitabine, Radiation: Neoadjuvant RadiotherapyA total of 33 pMMR/MSS LARC patients will receive long-course chemoradiotherapy plus 2 cycles of AK104, followed by another 3 cycles of AK104, finally received clinical routine manage. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-75
- ECOG 0-1
- Rectal adenocarcinoma
- cT3-4aNany or cT1-4aN+
- No distant metastasis
Key exclusion criteria (14 listed)
- bowel obstruction
- Distant metastasis
- Severe arrhythmia, cardiac dysfunction (NYHA grade III or IV )
- Uncontrollable severe hypertesion
- Active severe infection
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 |
|---|---|---|
| AK104Also: CadonilimabDuring neo-CRT: 2 cycles of AK104, 10mg/kg d1 q3w. After neo-CRT: 3 cycles of AK104, 10mg/kg d1 q3w. | Drug | Treatment Arm |
| CapecitabineDuring neo-CRT: 825mg/m2 bid Monday-Friday per week | Drug | Treatment Arm |
| Neoadjuvant RadiotherapyIMRT DT: 50Gy/25Fx | Radiation | Treatment Arm |
Primary outcome
Complete response (CR) rate
Time frame: an average of 6 months.
Rate of complete response (CR), including pathologic complete response (pCR) and clinical complete response (cCR).
7 secondary outcomes
Adverse effects
Time frame: From date of randomization until the date of death from any cause, assessed up to 5 years
Rate of Major pathologic response and tumor regression grade distribution
Time frame: an average of 1 year.
Rate of surgical complications
Time frame: The surgery was scheduled 2-4 weeks after the end of neoadjuvant therapy. And the surgical complications were assessed up to 1 year from the surgery.
Disease free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Local recurrence free survival
Time frame: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months.
Long-term anal function
Time frame: 1.5 year after diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK104, Capecitabine and Neoadjuvant Radiotherapy in people with Locally Advanced Rectal Cancer, run by Sun Yat-sen University at 1 site 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 10 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WeiWei Xiao (8613710390520 ext. 8613710390520, xiaoww@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (CR) rate (time frame: an average of 6 months.). 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 7 Feb 2024.