ClinicalTrials.gg
RecruitingNCT07751341Updated Sep 16, 2026

A Clinical Study of SHR-9839 as Monotherapy or in Combination With Chemotherapy Plus Adebrelimab Versus Chemotherapy Plus Adebrelimab in Patients With Advanced Esophageal Squamous Cell Carcinoma

A Phase 2 interventional study of SHR-9839(sc) for Injection and SHR-9839(sc) for Injection、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion in Advanced Esophageal Squamous Cell Carcinoma, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 401 studies in Esophageal Squamous Cell Carcinoma with a site in China — 174 open to participants now, 213 under way, 32 of them phase 3. Esophageal Squamous Cell Carcinoma · China.

Planned enrollment
156th of 351
84 · median 70
Started
2026
with 47 others
Phase 2
212 of 401
96 open now
Primary completion
2027-12
later than 152 of 212 live
Registered
391st of 401
by date

Among the 401 studies in Esophageal Squamous Cell Carcinoma with a site in China, this one is the 156th largest by planned enrollment of the 351 interventional ones that give a count, is one of 48 that started in 2026, is one of 212 in phase 2, reaches primary completion later than 152 of the 212 other live ones, and was the 391st registered.

Esophageal Squamous Cell Carcinoma

675 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 267 are open to participants now.

Browse Esophageal Squamous Cell Carcinoma studies →

Open to participants now

174 of the 401 studies in Esophageal Squamous Cell Carcinoma with a site in China are open now. Recruiting first, the newest first:

168 more — sign in →

All 174 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 180 Esophageal Squamous Cell Carcinoma studies recruiting now, 83 (46%) set no upper age limit and 76 (42%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 401 studies in Esophageal Squamous Cell Carcinoma with a site in China, or all of them as a file.
02

Study summary

An open-label, multicenter, randomized, phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839(sc) as monotherapy or in combination with chemotherapy plus adebelimab in patients with advanced esophageal squamous cell carcinoma (ESCC).

03

Conditions studied

  • Advanced Esophageal Squamous Cell Carcinoma
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Capable of providing ; has signed and dated the IRB/EC-approved informed consent form, and is willing and able to comply with scheduled study visits, examinations and all other protocol-specified procedures.
  2. Aged between 18 and 75 years inclusive at the time of informed consent signature, irrespective of gender.
  3. (ECOG) performance status of 0 or 1.
  4. Histopathologically confirmed locally advanced unresectable or esophageal squamous cell carcinoma (ESCC).
  5. Expected survival ≥12 weeks.
  6. Must provide a minimum of 11 formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks or unstained tumor slides.
  7. Females of must agree to use adequate effective from the date of informed consent, throughout study treatment, and for 9 months after the last dose of product, and refrain from oocyte donation during this period (refer to subsequent section for detailed contraceptive requirements).

Exclusion criteria

Exclusion Criteria:

  1. Uncontrolled or symptomatic active central nervous system (CNS) without adequate prior treatment.
  2. History of another concurrent malignant tumor diagnosed within 3 years prior to the first study drug administration.
  3. Presence of uncontrolled tumor-related pain as assessed by the Investigator.
  4. Severe cardiovascular or cerebrovascular diseases.
  5. History of interstitial lung disease (ILD) including idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans organizing pneumonia), drug-induced pneumonitis, radiation pneumonitis requiring therapy; or suspected/unruled-out ILD on screening imaging; or moderate-to-severe pulmonary disease severely impairing respiratory function.
  6. Severe infection within 4 weeks before study treatment initiation, including but not limited to bacteremia, severe pneumonia or other infectious complications requiring hospitalization; active Grade ≥2 infection requiring systemic antibiotics within 2 weeks prior to first dose (subjects on prophylactic antibiotics e.g., for urinary tract infection prophylaxis are eligible).
  7. History of immunodeficiency including positive serology; active (positive HBsAg at screening plus HBV-DNA ≥2500 copies/mL /500 IU/mL or above local laboratory cutoff); or active (positive anti-HCV plus detectable HCV RNA).
  8. Active pulmonary tuberculosis within 1 year before enrollment by medical history or imaging; or prior active pulmonary tuberculosis >1 year ago without standardized anti-tuberculosis treatment.
  9. Toxicities/complications from prior anti-tumor therapies not recovered to NCI-CTCAE Grade ≤1 or levels specified by eligibility criteria; subjects with Grade ≤2 toxicities may enroll if deemed without safety risk by the Investigator.
  10. Receipt of any systemic anti-cancer therapy within 4 weeks prior to study treatment start.
  11. Thoracic radiotherapy >30 Gy within 24 weeks, non-thoracic radiotherapy >30 Gy within 4 weeks before first dose; palliative radiotherapy ≤30 Gy within 14 days before first dose (exception: subjects completing radiotherapy ≥14 days prior to first dose are permitted). For prior radioisotope therapy, a of at least five half-lives of the radioisotope is required before study enrollment.
  12. Major organ surgery (excluding core needle ) or significant trauma within 4 weeks before first study drug, or planned elective surgery during trial participation; invasive minor surgery (biopsy, endoscopy, drainage procedure) within 7 days prior to first dose.
  13. Any other condition judged by the Investigator likely to interfere with trial conduct or subject safety, such as alcohol/drug abuse, uncontrolled severe illness (including psychiatric disorders) requiring concomitant medication, abnormal laboratory findings, familial/social issues or other factors compromising subject safety or data integrity.
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    Treatment group A

    Drug: SHR-9839(sc) for Injection

  • Experimental
    Treatment group B : Safety run-in Stage/Dose extension Stage

    Drug: SHR-9839(sc) for Injection、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion

Interventions

06

What researchers measure

Primary outcomes

  1. ORR:Objective Response Rate

    Time frame: First administration to end of treatment visit about 1year

Secondary outcomes

  1. DOR:Duration of relief

    Time frame: First administration to disease progression about 1 year

  2. DCR:Disease Control Rate

    Time frame: First administration to disease progression about 1 year

  3. PFS:progression-free survival

    Time frame: First administration to disease progression about 1 year

  4. OS:Overall Survival

    Time frame: First administration until participant's death about 2 years

  5. DLT:The Dose-Limiting Toxicity

    Time frame: Post-dose at day 1 to Day21

  6. MTD: The Maximum Tolerated Dose

    Time frame: Post-dose at day 1 to Day21

  7. AE:Incidence and severity of adverse events

    Time frame: Sign the informed consent form until Safety follow-up completed about 1 year

  8. ADA :Anti-Drug Antibody

    Time frame: Day1 pre-dose to 30 days after the last dose about 1 year

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Dec 2027, 15 months after the start.

Of 173 phase 2 interventional studies under Esophageal Squamous Cell Carcinoma, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 52. This study's planned 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2026
First posted
Aug 7, 2026
StartActual
Sep 7, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2028
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07751341
Responsible party
Sponsor
First posted
Aug 7, 2026
Start date
Sep 7, 2026
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Sep 16, 2026

Study contacts

Lin Ma
Contact
lin.ma.lm60@hengrui.com
+86 021-61053363
Cong Wen
Contact
cong.wen@hengrui.com
+86 021-61053363

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: SHR-9839

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