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Rectal AdenocarcinomaPhase 2STARNCT07669220

A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR/MSS Lower Rectal Adenocarcinoma (STAR Trial)

A Phase 2 study testing Short-course Radiotherapy, SCRT and Toripalimab in people with Rectal Adenocarcinoma and High-risk Locally Advanced, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study adopts a prospective randomized controlled design to evaluate the efficacy and safety of short-course radiotherapy followed by sequential PD-1 inhibitor and FOLFOX chemotherapy versus conventional regimens in high-risk locally advanced pMMR/MSS lower rectal adenocarcinoma, aiming to provide high-level… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Short-course Radiotherapy, SCRT and Toripalimab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteChina
Study dates
1 Jan 2026to 1 Jan 2028
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

  • Before implementing any procedures related to the study protocol rather than routine clinical care, a signed and dated informed consent form must be obtained from the subject voluntarily, in accordance with regulatory requirements and institutional guidelines.
  • Age 18-75 years.
  • Histologically or cytologically confirmed pMMR/MSS rectal adenocarcinoma.
  • The lower edge of the rectal tumor is located below the peritoneal reflection.
  • Locally advanced disease with high-risk factors, meeting at least one of the following: cT4 / cN2 / EMVI+ / MRF+ / positive lateral lymph node.
  • No clear evidence of distant metastasis prior to treatment.
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  • No prior anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).
  • ECOG performance status 0-1 (Appendix 1).
  • Peripheral blood counts and liver and renal function within the following ranges (tested within 15 days before treatment initiation):
  • White blood cell count (WBC) ≥ 3.0 × 10⁹/L or absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;
  • Hemoglobin (HGB) ≥ 80 g/L; ③ Platelet count (PLT) ≥ 100 × 10⁹/L; ④ Hepatic transaminases (AST/ALT) < 3.0 × upper limit of normal (ULN); ⑤ Total bilirubin (TBIL) < 1.5 × ULN; ⑥ Creatinine (CREAT) < 1.5 × ULN.
  • No history of other concurrent malignancies; not pregnant or lactating; effective contraceptive methods should be used during the study period and for 6 months after the last dose.

Who cannot join

  • Patients with a history of severe drug allergy (including allergy to platinum agents, 5-FU, and 5-HT3 receptor antagonists).
  • Patients who have participated in or are currently participating in another clinical trial within 4 weeks prior to enrollment.
  • History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any other therapy specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Severe electrolyte abnormalities.
  • Presence of gastrointestinal diseases such as active gastric or duodenal ulcer, ulcerative colitis, or unresected tumor with active bleeding; or other conditions that may cause gastrointestinal bleeding or perforation; or unhealed gastrointestinal perforation after surgical treatment.
  • History of arterial thrombosis or deep vein thrombosis within 6 months; evidence of bleeding tendency or hemorrhagic history within 2 months; currently receiving high-dose anticoagulation therapy.
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  • Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test prior to the first dose; or female participants and their partners who are unwilling to practice strict contraception during the study period.
  • Presence of other concurrent or prior active malignancies (except for malignancies that have been curatively treated with no recurrence for more than 3 years, or carcinoma in situ that can be cured by adequate treatment).
  • Severe electrocardiogram abnormalities, or active coronary artery disease, severe/unstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or congestive heart failure of NYHA Class II or higher.
  • Patients with active infection (infection causing fever > 38°C).
  • Patients with poorly controlled hypercalcemia, hypertension, or diabetes mellitus.
  • Patients with severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.).
  • Patients with mental disorders affecting clinical treatment or a history of central nervous system disease.
  • Patients with severe complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.).
  • Presence of any unresolved toxicity of CTCAE Grade 2 or higher resulting from prior therapy (except for anemia, alopecia, and skin pigmentation).
  • Any medical condition that is unstable or may affect patient safety and compliance with the study.
  • Patients deemed by the investigator to be unsuitable for participation in this clinical trial.

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

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou

    YiFeng Zou, 13719225862, zouyif@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

This study adopts a prospective randomized controlled design to evaluate the efficacy and safety of short-course radiotherapy followed by sequential PD-1 inhibitor and FOLFOX chemotherapy versus conventional regimens in high-risk locally advanced pMMR/MSS lower rectal adenocarcinoma, aiming to provide high-level evidence supporting a novel treatment paradigm.

Being tested
Short-course Radiotherapy, SCRT, Toripalimab
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Short-course Radiotherapy, SCRTRadiation

    The neoadjuvant treatment phase includes either SCRT followed by 6 cycles of FOLFOX chemotherapy combined with a PD-1 inhibitor, or LCRT concurrent with 6 cycles of FOLFOX chemotherapy. Surgery is performed 2-4 weeks after the last cycle of chemotherapy. If reassessment indicates cCR and N0, options include Total Mesorectal Excision (TME), local excision (LE), or watch and wait (W\&W); otherwise, TME is performed. Postoperative adjuvant chemotherapy follows the CAPOX regimen.

  • ToripalimabDrug

    The neoadjuvant treatment phase includes either SCRT followed by 6 cycles of FOLFOX chemotherapy combined with a PD-1 inhibitor, or LCRT concurrent with 6 cycles of FOLFOX chemotherapy. Surgery is performed 2-4 weeks after the last cycle of chemotherapy. If reassessment indicates cCR and N0, options include Total Mesorectal Excision (TME), local excision (LE), or watch and wait (W\&W); otherwise, TME is performed. Postoperative adjuvant chemotherapy follows the CAPOX regimen.

Study groups in NCT07669220
Study groupRoleWhat they receive
SCRT-PD1-FOLFOXExperimentalNot described
Receives: Radiation: Short-course Radiotherapy, SCRT; Drug: Toripalimab
LCRT-FOLFOXActive comparatorNot described
Receives: Radiation: Short-course Radiotherapy, SCRT; Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CCR

    cCR+pCR

    Measured: 3 years

Secondary outcomes (7)

  1. 3-year RFS

    Measured: 3 years

  2. 3-year DFS

    Measured: 3 years

  3. 3-year OS

    Measured: 3 years

  4. 3-year DMFS

    Measured: 3 years

  5. R0 Resection Rate

    Measured: 3 years

  6. MPR Rate

    Measured: 3 years

  7. Treatment-Related Adverse Events / Treatment Toxicity

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2026
  2. Study start1 Jan 2026
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07669220
Sponsor's protocol ID
2026ZSLYEC-285
Acronym
STAR
Status last verified
Jun 2026
First submitted
21 Jun 2026
Last updated
25 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Short-course Radiotherapy, SCRT and Toripalimab in people with Rectal Adenocarcinoma and High-risk Locally Advanced, run by Sixth Affiliated Hospital, 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 12 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 25 Jun 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CCR (time frame: 3 years). 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 NCT07669220.

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 25 Jun 2026.

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