Locally Advanced Rectal CancerPhase 2NCT05300269
SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
A Phase 2 study testing SHR-1701；Capecitabine；Oxaliplatin in people with Locally Advanced Rectal Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of SHR-1701 combined with radiotherapy and chemotherapy as perioperative treatment for locally advanced rectal cancer. Eligible patients will receive standard chemoradiation with SHR-1701 followed by XELOX combined with SHR-1701. 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?
- SHR-1701；Capecitabine；Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2022to 31 Oct 2026
- 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
- Be willing and able to provide written informed consent for the trial.
- Locally advanced rectal adenocarcinoma and was evaluated as resectable ;
- The inferior margin of the tumor ≤ 10 cm from the anal verge ;
- No prior anti-cancer treatment for rectal cancer;
- Estern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1;
- Adequate hematologic and end-organ function;
- Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug
Who cannot join
- Unresectable disease determined by investigators
- Recurrent rectal cancer
- Evidence of metastatic disease or lateral lymph node metastases
- Presence of synchronous colorectal cancer
- Presence of obstruction or imminent obstruction
- Not eligible for long-course radiotherapy
- Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlled
- Prior malignancy within the prior 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical/breast cancer.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Jianmin Xu
About this study
Official title: SHR-1701 in Combination With Radiotherapy and Chemotherapy as Perioperative Treatment for Resectable Locally Advanced Rectal Cancer, an Open Label, Single-arm, Multicenter Phase II Trial
This study will evaluate the efficacy and safety of SHR-1701 combined with radiotherapy and chemotherapy as perioperative treatment for locally advanced rectal cancer. Eligible patients will receive standard chemoradiation with SHR-1701 followed by XELOX combined with SHR-1701. In all subjects, restaging pelvic MRI with chest and abdominal CT will be performed after completion of neoadjuvant treatment to determine resectability and to rule out any evidence of metastases. Subjects who have resectable disease will undergo surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- SHR-1701；Capecitabine；Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701；Capecitabine；OxaliplatinDrug
Radiation: Radiation therapy 50.4Gy in 28 fractions to the pelvis on Days 1-5 every week. Drug: Capecitabine Capecitabine 825mg/m^2 orally twice daily (bid) 5 days/week during radiotherapy.
Drug:SHR-1701 Drug: Capecitabine (XELOX) Capecitabine 1000mg/m^2 orally twice daily (bid) day1-day14, q3w. Drug: Oxaliplatin Oxaliplatin 130mg/m^2, day1, iv, q3w
| Study group | Role | What they receive |
|---|---|---|
| Perioperative treatment | Experimental | Eligible subjects will receive standard chemoradiotherapy with SHR-1701 followed by XELOX combined with SHR-1701 and surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery. Receives: Drug: SHR-1701；Capecitabine；Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measured: At week 16, DAY1
Percentage of participants with Pathological complete response ( pCR )
Measured: At week 16, DAY1
Secondary outcomes (6)
Tumor regression grade ( TRG )
Measured: At week 16, DAY1
Percentage of participants with R0 Resection ( R0 )
Measured: At week 16, DAY1
Percentage of participants with Clinical complete response ( cCR ) rate.
Measured: At week 16, DAY1
Event-free survival ( EFS )
Measured: Year 1, Year 2, Year 3
Overall survival ( OS )
Measured: Year 1, Year 2, Year 3
Disease-free survival ( DFS )
Measured: Year 1, Year 2, Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start5 Jul 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The 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
- Model description
- A multicenter, open, single-arm, two-stage phase II clinical study
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300269
- Sponsor's protocol ID
- SHR-1701-II-213
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tang W, Lv Y, Xie H, Wei Y, Wang J, Yu M, Jiang Y, Mao R, Huang C, Rao S, Ding K, Chang W, He G, Xu J. Efficacy and safety of SHR-1701 combined with chemoradiotherapy as neoadjuvant treatment for locally advanced rectal cancer. Cancer Lett. 2026 Jan 1;636:218006. doi: 10.1016/j.canlet.2025.218006. Epub 2025 Aug 26.
PubMed 40876501
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHR-1701 in Combination With Radiotherapy and Chemotherapy as Perioperative Treatment for Resectable Locally Advanced Rectal Cancer, an Open Label, Single-arm, Multicenter Phase II Trial
- ClinicalTrials.gov ID
- NCT05300269
- Acronym / sponsor ID
- SHR-1701-II-213
- Conditions
- Locally Advanced Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 29 Mar 2022 (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 study will evaluate the efficacy and safety of SHR-1701 combined with radiotherapy and chemotherapy as perioperative treatment for locally advanced rectal cancer. Eligible patients will receive standard chemoradiation with SHR-1701 followed by XELOX combined with SHR-1701. In all subjects, restaging pelvic MRI with chest and abdominal CT will be performed after completion of neoadjuvant treatment to determine resectability and to rule out any evidence of metastases. Subjects who have resectable disease will undergo surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A multicenter, open, single-arm, two-stage phase II clinical study
| Arm | Type | Receives |
|---|---|---|
| Perioperative treatment | Experimental | Drug: SHR-1701；Capecitabine；OxaliplatinEligible subjects will receive standard chemoradiotherapy with SHR-1701 followed by XELOX combined with SHR-1701 and surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be willing and able to provide written informed consent for the trial.
- Locally advanced rectal adenocarcinoma and was evaluated as resectable ;
- The inferior margin of the tumor ≤ 10 cm from the anal verge ;
- No prior anti-cancer treatment for rectal cancer;
- Estern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1;
Key exclusion criteria (8 listed)
- Unresectable disease determined by investigators
- Recurrent rectal cancer
- Evidence of metastatic disease or lateral lymph node metastases
- Presence of synchronous colorectal cancer
- Presence of obstruction or imminent obstruction
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 |
|---|---|---|
| SHR-1701；Capecitabine；OxaliplatinRadiation: Radiation therapy 50.4Gy in 28 fractions to the pelvis on Days 1-5 every week. Drug: Capecitabine Capecitabine 825mg/m^2 orally twice daily (bid) 5 days/week during radiotherapy. Drug:SHR-1701 Drug: Capecitabine (XELOX) Capecitabine 1000mg/m^2 orally twice daily (bid) day1-day14, q3w. Drug: Oxaliplatin Oxaliplatin 130mg/m^2, day1, iv, q3w | Drug | Perioperative treatment |
Primary outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: At week 16, DAY1
Percentage of participants with Pathological complete response ( pCR )
Time frame: At week 16, DAY1
6 secondary outcomes
Tumor regression grade ( TRG )
Time frame: At week 16, DAY1
Percentage of participants with R0 Resection ( R0 )
Time frame: At week 16, DAY1
Percentage of participants with Clinical complete response ( cCR ) rate.
Time frame: At week 16, DAY1
Event-free survival ( EFS )
Time frame: Year 1, Year 2, Year 3
Overall survival ( OS )
Time frame: Year 1, Year 2, Year 3
Disease-free survival ( DFS )
Time frame: Year 1, Year 2, Year 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Derived from this study: PubMed 40876501Tang W, Lv Y, Xie H, Wei Y, Wang J, Yu M, Jiang Y, Mao R, Huang C, Rao S, Ding K, Chang W, He G, Xu J. Efficacy and safety of SHR-1701 combined with chemoradiotherapy as neoadjuvant treatment for locally advanced rectal cancer. Cancer Lett. 2026 Jan 1;636:218006. doi: 10.1016/j.canlet.2025.218006. Epub 2025 Aug 26.
- 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 SHR-1701；Capecitabine；Oxaliplatin in people with Locally Advanced Rectal Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. 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 7 inclusion and 8 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 29 Jul 2022. 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 Qing Yang, M.D (+86 021-61053363, qing.yang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 (time frame: At week 16, DAY1). 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?
On the ClinicalTrials.gov record for NCT05300269, which also lists 1 linked publication.
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 29 Jul 2022.