Rectal CancerPhase 2SPARENCT07810114
Total Neoadjuvant mFOLFOX6 Plus Suvemcitug and Enlonstobart With Selective Omission of Pelvic Radiotherapy for High-Risk Mid-Rectal Locally Advanced Rectal Cancer
A Phase 2 study testing mFOLFOX6, Suvemcitug and Enlonstobart in people with Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, multicenter, open-label, single-arm Phase II study designed to evaluate the efficacy and safety of total neoadjuvant mFOLFOX6 combined with suvemcitug and enlonstobart in patients with MRI（Magnetic Resonance Imaging）-defined high-risk, mid-rectal, locally advanced rectal adenocarcinoma with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- mFOLFOX6, Suvemcitug and Enlonstobart
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2026to 1 Dec 2030
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years, male or female.
- Histologically confirmed rectal adenocarcinoma.
- pMMR or MSS status confirmed by genetic testing or immunohistochemistry.
- Tumor lower margin located 5-12 cm from the anal verge, based on colonoscopy or MRI, consistent with mid-rectal cancer.
- Pelvic MRI showing high-risk locally advanced rectal cancer, meeting at least one of the following criteria: cT3c/d, defined as tumor extension >5 mm beyond the muscularis propria; cN2 disease, defined as >=4 regional metastatic lymph nodes; definite extramural venous invasion positivity.
- No distant metastasis confirmed by chest and abdominal imaging, including contrast-enhanced CT or MRI.
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- ECOG performance status of 0 or 1.
- Adequate organ function, including absolute neutrophil count >=1.5 x 10^9/L; platelet count >=100 x 10^9/L; hemoglobin >=9 g/dL; ALT and AST <=2.5 x upper limit of normal; total bilirubin <=1.5 x upper limit of normal; serum creatinine <=1.5 x upper limit of normal or creatinine clearance >=50 mL/min.
- Not pregnant or breastfeeding. Participants of reproductive potential must agree to use effective contraception during study treatment and for the protocol-specified period after the last dose.
- Voluntary participation with signed written informed consent.
Who cannot join
- Imaging evidence of cT4 disease, mesorectal fascia positivity, or lateral lymph node metastasis.
- Prior pelvic radiotherapy or prior systemic antitumor treatment for the current disease, including chemotherapy, targeted therapy, or immunotherapy.
- Special histologic subtypes, including mucinous adenocarcinoma, signet-ring cell carcinoma, undifferentiated carcinoma, or other special histologic types.
- Known allergy or contraindication to any component of the study drugs, including oxaliplatin, 5-fluorouracil, suvemcitug, or enlonstobart.
- Active or previous severe autoimmune disease, including systemic lupus erythematosus or inflammatory bowel disease, or long-term use of systemic immunosuppressive agents.
- Serious cardiovascular events within 6 months, including acute myocardial infarction or stroke, refractory hypertension, or NYHA class III-IV heart failure.
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- Active infection, including active tuberculosis, uncontrolled hepatitis B or C, or HIV infection with high viral load.
- Other malignancy within 5 years, except cured localized skin cancer or carcinoma in situ.
- Pregnancy or breastfeeding.
- Inability to undergo MRI examination.
- Multiple primary colorectal cancers.
- Intestinal obstruction, intestinal perforation, or high risk of obstruction or perforation.
- Hypertension that cannot be controlled to the normal range with antihypertensive therapy, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg.
- NYHA class III-IV cardiac insufficiency or left ventricular ejection fraction <50% on echocardiography.
- Proteinuria, defined as urine protein >1+ at screening, or urine protein 1+ that does not return to normal on repeat testing within 24 hours.
- Definite tendency for gastrointestinal bleeding, including active local ulcerative lesions with fecal occult blood positivity of ++; history of melena or hematemesis within 2 months; high risk of bleeding such as grade >=3 bleeding within 6 months, hemoptysis >=2.5 mL per episode, imaging evidence of tumor invasion into major blood vessels, or bleeding risk deemed unacceptable by the investigator.
- High risk of gastrointestinal perforation or fistula, including gastrointestinal perforation or active peptic ulcer within 6 months, or pelvic tumor invasion of the bladder or rectum with potential fistula risk as judged by the investigator.
- Coagulation abnormality, including INR >1.5 or APTT >1.5 x upper limit of normal, with bleeding tendency.
- Chronic unhealed wound or fracture; major surgery within 4 weeks; or severe traumatic injury, fracture, or ulcer within 4 weeks.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment or unlikely to comply with follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tang contact
China1 site
Department of General Surgery, Zhongshan Hospital, Fudan University
Shanghai, 200032
About this study
Official title: A Phase II Study of Total Neoadjuvant mFOLFOX6 Plus Suvemcitug and Enlonstobart With Selective Omission of Pelvic Radiotherapy for High-Risk Mid-Rectal Locally Advanced Rectal Cancer With MSS Status
This is a prospective, multicenter, open-label, single-arm Phase II study designed to evaluate the efficacy and safety of total neoadjuvant mFOLFOX6 combined with suvemcitug and enlonstobart in patients with MRI（Magnetic Resonance Imaging）-defined high-risk, mid-rectal, locally advanced rectal adenocarcinoma with pMMR/MSS status.
All enrolled participants will receive 6 cycles of mFOLFOX6 plus suvemcitug and enlonstobart every 2 weeks. After 6 cycles, participants will undergo reassessment with pelvic MRI and systemic imaging. Participants who achieve at least 20% tumor regression on MRI without new high-risk radiologic features will continue with 2 additional cycles of mFOLFOX6 followed by radical total mesorectal excision surgery, without routine pelvic radiotherapy. Participants who do not meet the predefined regression threshold or show disease progression will receive long-course chemoradiotherapy with concurrent capecitabine, followed by 3 cycles of mFOLFOX6 and radical surgery.
- Conditions
- Rectal Cancer
- Being tested
- mFOLFOX6, Suvemcitug, Enlonstobart, Pelvic Chemoradiotherapy, Total Mesorectal Excision
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFOX6Drug
Oxaliplatin 85 mg/m2 IV over 2 hours on Day 1; leucovorin calcium 400 mg/m2 IV over 2 hours on Day 1; 5-fluorouracil 400 mg/m2 IV bolus on Day 1; 5-fluorouracil 2400 mg/m2 continuous IV infusion over 46-48 hours;every 2 weeks, for 6 cycles during the initial total neoadjuvant treatment phase.
Participants meeting the predefined MRI regression criterion will receive 2 additional cycles of mFOLFOX6 before surgery. Participants requiring chemoradiotherapy will receive 3 additional cycles of mFOLFOX6 after long-course chemoradiotherapy before surgery.
SuvemcitugDrug
Suvemcitug 2 mg/kg IV infusion on Day 1 of each 14-day cycle, every 2 weeks, for 6 doses during the initial total neoadjuvant treatment phase.
EnlonstobartDrug
Enlonstobart 240 mg IV infusion on Day 1 of each 14-day cycle, every 2 weeks, for 6 doses during the initial total neoadjuvant treatment phase.
Pelvic ChemoradiotherapyRadiation
Used selectively for participants who do not achieve the predefined interim MRI regression threshold or who show disease progression.
45-50.4 Gy in 25-28 fractions. Oral capecitabine during radiotherapy.
Total Mesorectal ExcisionProcedure or surgery
For participants omitting radiotherapy: approximately 2-4 weeks after completion of total neoadjuvant systemic therapy. For participants receiving chemoradiotherapy: after long-course chemoradiotherapy and subsequent mFOLFOX6 treatment, according to investigator assessment.
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOX6 combined with suvemcitug and enlonstobart | Experimental | Participants will receive total neoadjuvant therapy with mFOLFOX6 plus suvemcitug and enlonstobart for 6 cycles. After interim radiologic reassessment, participants with MRI tumor regression >=20% and no new high-risk radiologic findings will continue with 2 additional cycles of mFOLFOX6 followed by radical TME（Total Mesorectal Excision） surgery without routine pelvic radiotherapy. Participants with tumor regression <20% or disease progression will receive long-course pelvic chemoradiotherapy with concurrent capecitabine, followed by 3 cycles of mFOLFOX6 and radical TME surgery. Receives: Drug: mFOLFOX6; Drug: Suvemcitug; Drug: Enlonstobart; Radiation: Pelvic Chemoradiotherapy; Procedure: Total Mesorectal Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response Rate
Measured: Perioperative : at the time of surgery for pCR（Pathologic Complete Response Rate）.
Secondary outcomes (7)
R0 Resection Rate
Measured: Perioperative : at the time of surgery.
Circumferential Resection Margin Negative Rate
Measured: Perioperative : at the time of surgery.
Major Pathologic Response Rate
Measured: Perioperative : at the time of surgery.
Proportion of Participants Receiving Pelvic Radiotherapy
Measured: At the end of Cycle 6 (each cycle is 14 days)"
Successful Radiotherapy Omission Rate
Measured: From enrollment to surgery.
Three-Year Disease-Free Survival
Measured: Up to 3 years after surgery
Quality of life will be evaluated using the European O-rganization for Reasearch and Treatment of Cancer Quality of Life Questionnaire-C30（EORTC QLQ-C30） (range 0-100).
It evaluates the quality of life from 30 aspects, including appetite, mental status, sleep quality, fatigue, etc. The higher scores mean a better quality of life.
Measured: Baseline, At the end of Cycle 6 (each cycle is 14 days),Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start28 Aug 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2030 (estimated)
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.
- More trials run by Fudan 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810114
- Sponsor's protocol ID
- SPARE
- Acronym
- SPARE
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Total Neoadjuvant mFOLFOX6 Plus Suvemcitug and Enlonstobart With Selective Omission of Pelvic Radiotherapy for High-Risk Mid-Rectal Locally Advanced Rectal Cancer With MSS Status
- ClinicalTrials.gov ID
- NCT07810114
- Acronym / sponsor ID
- SPARE / SPARE
- Conditions
- Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 28 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 9 Sep 2026 (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 a prospective, multicenter, open-label, single-arm Phase II study designed to evaluate the efficacy and safety of total neoadjuvant mFOLFOX6 combined with suvemcitug and enlonstobart in patients with MRI（Magnetic Resonance Imaging）-defined high-risk, mid-rectal, locally advanced rectal adenocarcinoma with pMMR/MSS status.
All enrolled participants will receive 6 cycles of mFOLFOX6 plus suvemcitug and enlonstobart every 2 weeks. After 6 cycles, participants will undergo reassessment with pelvic MRI and systemic imaging. Participants who achieve at least 20% tumor regression on MRI without new high-risk radiologic features will continue with 2 additional cycles of mFOLFOX6 followed by radical total mesorectal excision surgery, without routine pelvic radiotherapy. Participants who do not meet the predefined regression threshold or show disease progression will receive long-course chemoradiotherapy with concurrent capecitabine, followed by 3 cycles of mFOLFOX6 and radical surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mFOLFOX6 combined with suvemcitug and enlonstobart | Experimental | Drug: mFOLFOX6, Drug: Suvemcitug, Drug: Enlonstobart, Radiation: Pelvic Chemoradiotherapy, Procedure: Total Mesorectal ExcisionParticipants will receive total neoadjuvant therapy with mFOLFOX6 plus suvemcitug and enlonstobart for 6 cycles. After interim radiologic reassessment, participants with MRI tumor regression >=20% and no new high-risk radiologic findings will continue with 2 additional cycles of mFOLFOX6 followed by radical TME（Total Mesorectal Excision） surgery without routine pelvic radiotherapy. Participants with tumor regression <20% or disease progression will receive long-course pelvic chemoradiotherapy with concurrent capecitabine, followed by 3 cycles of mFOLFOX6 and radical TME surgery. |
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 to 75 years, male or female.
- Histologically confirmed rectal adenocarcinoma.
- pMMR or MSS status confirmed by genetic testing or immunohistochemistry.
- Tumor lower margin located 5-12 cm from the anal verge, based on colonoscopy or MRI, consistent with mid-rectal cancer.
- Pelvic MRI showing high-risk locally advanced rectal cancer, meeting at least one of the following criteria: cT3c/d, defined as tumor extension >5 mm beyond the muscularis propria; cN2 disease, defined as >=4 regional metastatic lymph nodes; definite extramural venous invasion positivity.
Key exclusion criteria (20 listed)
- Imaging evidence of cT4 disease, mesorectal fascia positivity, or lateral lymph node metastasis.
- Prior pelvic radiotherapy or prior systemic antitumor treatment for the current disease, including chemotherapy, targeted therapy, or immunotherapy.
- Special histologic subtypes, including mucinous adenocarcinoma, signet-ring cell carcinoma, undifferentiated carcinoma, or other special histologic types.
- Known allergy or contraindication to any component of the study drugs, including oxaliplatin, 5-fluorouracil, suvemcitug, or enlonstobart.
- Active or previous severe autoimmune disease, including systemic lupus erythematosus or inflammatory bowel disease, or long-term use of systemic immunosuppressive agents.
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 |
|---|---|---|
| mFOLFOX6Oxaliplatin 85 mg/m2 IV over 2 hours on Day 1; leucovorin calcium 400 mg/m2 IV over 2 hours on Day 1; 5-fluorouracil 400 mg/m2 IV bolus on Day 1; 5-fluorouracil 2400 mg/m2 continuous IV infusion over 46-48 hours;every 2 weeks, for 6 cycles during the initial total neoadjuvant treatment phase. Participants meeting the predefined MRI regression criterion will receive 2 additional cycles of mFOLFOX6 before surgery. Participants requiring chemoradiotherapy will receive 3 additional cycles of mFOLFOX6 after long-course chemoradiotherapy before surgery. | Drug | mFOLFOX6 combined with suvemcitug and enlonstobart |
| SuvemcitugSuvemcitug 2 mg/kg IV infusion on Day 1 of each 14-day cycle, every 2 weeks, for 6 doses during the initial total neoadjuvant treatment phase. | Drug | mFOLFOX6 combined with suvemcitug and enlonstobart |
| EnlonstobartEnlonstobart 240 mg IV infusion on Day 1 of each 14-day cycle, every 2 weeks, for 6 doses during the initial total neoadjuvant treatment phase. | Drug | mFOLFOX6 combined with suvemcitug and enlonstobart |
| Pelvic ChemoradiotherapyUsed selectively for participants who do not achieve the predefined interim MRI regression threshold or who show disease progression. 45-50.4 Gy in 25-28 fractions. Oral capecitabine during radiotherapy. | Radiation | mFOLFOX6 combined with suvemcitug and enlonstobart |
| Total Mesorectal ExcisionFor participants omitting radiotherapy: approximately 2-4 weeks after completion of total neoadjuvant systemic therapy. For participants receiving chemoradiotherapy: after long-course chemoradiotherapy and subsequent mFOLFOX6 treatment, according to investigator assessment. | Procedure or surgery | mFOLFOX6 combined with suvemcitug and enlonstobart |
Primary outcome
Pathologic Complete Response Rate
Time frame: Perioperative : at the time of surgery for pCR（Pathologic Complete Response Rate）.
7 secondary outcomes
R0 Resection Rate
Time frame: Perioperative : at the time of surgery.
Circumferential Resection Margin Negative Rate
Time frame: Perioperative : at the time of surgery.
Major Pathologic Response Rate
Time frame: Perioperative : at the time of surgery.
Proportion of Participants Receiving Pelvic Radiotherapy
Time frame: At the end of Cycle 6 (each cycle is 14 days)"
Successful Radiotherapy Omission Rate
Time frame: From enrollment to surgery.
Three-Year Disease-Free Survival
Time frame: Up to 3 years after surgery
Quality of life will be evaluated using the European O-rganization for Reasearch and Treatment of Cancer Quality of Life Questionnaire-C30（EORTC QLQ-C30） (range 0-100).
Time frame: Baseline, At the end of Cycle 6 (each cycle is 14 days),Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 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.
Tang contact
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 mFOLFOX6, Suvemcitug and Enlonstobart in people with Rectal Cancer, run by Fudan 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 20 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: opening soon, as of the sponsor's last update on 9 Sep 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 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?
Contact Wentao Tang (18317121626, tangwt1988@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response Rate (time frame: Perioperative : at the time of surgery for pCR（Pathologic Complete Response Rate）.). 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 9 Sep 2026.