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
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. Contact the study team or a site near you to ask about taking part.
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